FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® TENDER INFUSION SET
MDR report key: 3121613
·
Received May 21, 2013
Report
- Report Number
- 2183996-2013-00884
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- May 11, 2013
- Report Date
- July 26, 2013
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K972135
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED SAMPLE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
ON (B)(4) 2013, THE PATIENT REPORTED THAT HIS INFUSION SET WAS LEAKING. HE NOTICED THE LEAK WHEN HE NOTICED HIS SHIRT WAS WET. HE STATED THE LEAK WAS COMING FROM WHERE THE CANNULA CONNECTS TO THE HEADSET OF THE INFUSION SET. THE PATIENT CHANGED THE INFUSION SET AND HAD NO FURTHER PROBLEMS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223691 | ACCU-CHEK ® TENDER INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | UNOMEDICAL A/S | NA | 649823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 063 YR | KLONOPIN| TRYSIDONE| RAPANOL| SYMBALTA| HUMALOG| ABILIFIE| PLAVIX| ASPIRIN| AMBIAN |