FDA Adverse Event Malfunction Summary report: N

BD SYR 10ML SURESCRUB POSIFLUSH SALINE

MDR report key: 8713741 · Received June 19, 2019

Report

Report Number: 1911916-2019-00603
Event Type: Malfunction
Date Received: June 19, 2019
Date of Event: June 3, 2019
Report Date: June 4, 2019
Manufacturer: BD MEDICAL (BD WEST) MEDICAL SURGICAL
Product Code: NGT
UDI-DI: 30382903065593
PMA / PMN Number: SEE H.10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE TYPE: NGT; LKB. PMA / 510(K)#: K161552 (SYRINGE), K121655 (ALCOHOL PAD). INVESTIGATION SUMMARY: NO SAMPLE WAS RECEIVED. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR THE LOT# 8362820 FOR THE SAME DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8362820 DURING THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: ROOT CAUSE CAN¿T BE CONFIRMED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PLUNGER SEPARATED WITH A BD SYR 10ML SURESCRUB POSIFLUSH SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2). MATERIAL NO: 306559, BATCH NO: 8362820. IT WAS REPORTED THAT PLUNGER SEPARATES FROM SYRINGE. PER CUSTOMER EMAIL: ONE SYRINGE OUT OF THE BOX THAT DID POP OFF PRE-MATURELY. USED THE WHOLE BOX EXCEPT FOR 2 SYRINGES. SEEMS TO THINK THIS WAS MUCH BETTER AS WITH THE OTHER LOT SYRINGES, IT WAS HAPPENING VERY FREQUENTLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
505543	BD SYR 10ML SURESCRUB POSIFLUSH SALINE	SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT	NGT	BD MEDICAL (BD WEST) MEDICAL SURGICAL		8362820	30382903065593

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other