UKNOWN NASOGASTRIC TUBE
Report
- Report Number
- 1018233-2022-03311
- Event Type
- Injury
- Date Received
- May 5, 2022
- Date of Event
- March 21, 2022
- Report Date
- July 26, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- BSS
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "INCORRECT SET-UP". IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. UNABLE TO PERFORM LABELING REVIEW DUE TO UNKNOWN PRODUCT CODE. ALTHOUGH THE PRODUCT FAMILY WAS UNKNOWN, THE (UNKNOWN NG TUBE) PRODUCT IFUS WERE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. CORRECTION: G H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE NASOGASTRIC SALEM SUMP TUBE WAS WITH NO CLEAR MARKERS FOR INSERTION MEASUREMENT. IT WAS STATED THAT ON (B)(6) 2022, THE PATIENT HAD A TRAUMA. PATIENT WAS INTUBATED AND AN OROGASTRIC WAS PLACED. THE TUBE WAS COILED IN THE STOMACH AND NEEDED TO BE PULLED BACK. THE NURSES WERE UNABLE TO TELL HOW FAR THEY PULLED THE TUBE BACK OR HOW FAR THE TUBE WAS INSERTED INTO THE PATIENT. ALSO STATED THAT IT WAS DIFFICULT TO TRACK OF HOW FAR TO INSERT THE NASOGASTRIC TUBE INTO THE PATIENT WITH NO CLEAR MARKINGS. THIS POTENTIALLY LED TO COILING IN THE STOMACH AND NEEDING TO BE PULLED BACK. ONCE PULLED BACK, THE HOSPITAL STAFF TEAM WERE ALL UNABLE TO TELL HOW FAR THE TUBE WAS INSERTED. THE CURRENT BARD NASOGASTRIC TUBE DID NOT HAVE NUMERICAL NUMBERS IT USES GENERIC MARKERS MARKED AT 18-INCH, 22-INCH, 26-INCH, AND 30-INCH FROM DISTAL TIP. THE CUSTOMER RECOMMENDED TO SWITCH TO A NASOGASTRIC TUBE THAT HAS CLEAR MARKINGS TO IDENTIFY EXACTLY THE DISTANCE THE TUBE WAS INSERTED. MEDICAL INTERVENTION WAS UNKNOWN.
IT WAS REPORTED THAT THE NASOGASTRIC SALEM SUMP TUBE WAS WITH NO CLEAR MARKERS FOR INSERTION MEASUREMENT. IT WAS STATED THAT ON (B)(6) 2022, THE PATIENT HAD A TRAUMA. PATIENT WAS INTUBATED AND AN OROGASTRIC WAS PLACED. THE TUBE WAS COILED IN THE STOMACH AND NEEDED TO BE PULLED BACK. THE NURSES WERE UNABLE TO TELL HOW FAR THEY PULLED THE TUBE BACK OR HOW FAR THE TUBE WAS INSERTED INTO THE PATIENT. ALSO STATED THAT IT WAS DIFFICULT TO TRACK OF HOW FAR TO INSERT THE NASOGASTRIC TUBE INTO THE PATIENT WITH NO CLEAR MARKINGS. THIS POTENTIALLY LED TO COILING IN THE STOMACH AND NEEDING TO BE PULLED BACK. ONCE PULLED BACK, THE HOSPITAL STAFF TEAM WERE ALL UNABLE TO TELL HOW FAR THE TUBE WAS INSERTED. THE CURRENT BARD NASOGASTRIC TUBE DID NOT HAVE NUMERICAL NUMBERS IT USES GENERIC MARKERS MARKED AT 18-INCH, 22-INCH, 26-INCH, AND 30-INCH FROM DISTAL TIP. THE CUSTOMER RECOMMENDED TO SWITCH TO A NASOGASTRIC TUBE THAT HAS CLEAR MARKINGS TO IDENTIFY EXACTLY THE DISTANCE THE TUBE WAS INSERTED. MEDICAL INTERVENTION WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1380196 | UKNOWN NASOGASTRIC TUBE | UKNOWN NASOGASTRIC TUBE | BSS | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |