MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number 309572

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had mold on it.This was discovered before use.The following information was provided by the initial reporter: material no.309572 batch no.9203066.It was reported that mold was noticed on luer lok syringes when dispensing the syringes to a consumer.Pharmacist called to report mold on luer lok syringes (1) full box of individually wrapped syringes.Stated that she was dispensing the syringes to a consumer when she noticed the mold.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see section h.10.

Event Description

It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had mold on it.This was discovered before use.The following information was provided by the initial reporter: material no.309572 batch no.9203066 it was reported that mold was noticed on luer lok syringes when dispensing the syringes to a consumer.Pharmacist called to report mold on luer lok syringes (1) full box of individually wrapped syringes.Stated that she was dispensing the syringes to a consumer when she noticed the mold.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9395517
• MDR Text Key: 194839804
• Report Number: 1213809-2019-01194
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 309572
• Device Catalogue Number: 309572
• Device Lot Number: 9203066
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other