MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK SYRINGE WITH LUER-LOK TIP; PISTON SYRINGE

Catalog Number	305062
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Material no.305062, batch no.8281966.It was reported that before use of the bd plastipak¿ syringe with luer-lok¿ tip the tip was damaged.The following information was provided by the initial reporter: we have found in our inventory a bd 5ml syringe luer-lock tip with blunt fill needle 18g x 1 ½ with a damaged plunger tip.Customer called in to report an issue with bd 5 ml syringe.
Additional Manufacturer Narrative
H.6.Investigation: one photo and one 5ml syringe in an opened blister pack from batch 8281966 (p/n 305062) was received and evaluated.It was observed in the photo and physical sample a portion of the stopper was wedged between the plunger rod and the barrel wall.This was a rejetable condition per product specification.Potential root cause for the jammed stopper defect is associated with the assembly process.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.
Event or Problem Description
Material no.305062, batch no.8281966.It was reported that before use of the bd plastipak¿ syringe with luer-lok¿ tip the tip was damaged.The following information was provided by the initial reporter: we have found in our inventory a bd 5ml syringe luer-lock tip with blunt fill needle 18g x 1 ½ with a damaged plunger tip.Customer called in to report an issue with bd 5 ml syringe.

• Brand Name: BD PLASTIPAK SYRINGE WITH LUER-LOK TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8975049
• Report Number: 1213809-2019-00905
• Device Sequence Number: 19655218
• Product Code: FMF
• UDI-Device Identifier: 30382903050629
• UDI-Public: 30382903050629
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 305062
• Device Lot Number: 8281966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other