MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML LL 21X1 BULK CONV PAK

Catalog Number	303021
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.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
It was reported that 1 syringe 5ml ll 21x1 bulk conv pak had a cracked plunger, 1 syringe had a damaged barrel, 1 syringe had a missing stopper, and 1 syringe had a loose stopper.All defects were found before use in lot# 7093007.The following information was provided by the initial reporter: "syringe plunger cracked, defective barrel, missing or loose rubber gasket.".
Event or Problem Description
It was reported that before use, 1 syringe 5ml ll 21x1 bulk conv pak was found with a damaged barrel flange, and 1 syringe had a loose stopper.The following information was provided by the initial reporter: "syringe plunger cracked, defective barrel, missing or loose rubber gasket.".
Additional Manufacturer Narrative
Correction: additional information was received from the customer.The following fields have been updated: b.5.Describe event or problem: it was reported that before use, 1 syringe 5ml ll 21x1 bulk conv pak was found with a damaged barrel flange, and 1 syringe had a loose stopper.The following information was provided by the initial reporter: "syringe plunger cracked, defective barrel, missing or loose rubber gasket." f.10.Device codes: 1069, 1354.
Additional Manufacturer Narrative
H.6.Investigation summary : 3 photos were provided that shows the end of the barrel of a syringe damaged.Bd was unable to verify the two other defects reported without the actual sample available.The syringe is a component of the convenience pack assembled in a distribution center in four oaks, nc.The syringe lot number has been requested to the site contact.Unfortunately, bd has not received any additional information on the syringe lot that was reported.Without this information, an accurate device history review could not be conducted.If the sample pictured is still available, bd can re-open this record and analyze the sample more accurately.Since the sample is not available a definitive root cause could not be defined and no corrective actions are necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that 1 syringe 5ml ll 21x1 bulk conv pak had a cracked plunger, 1 syringe had a damaged barrel, 1 syringe had a missing stopper, and 1 syringe had a loose stopper.All defects were found before use in lot# 7093007.The following information was provided by the initial reporter: "syringe plunger cracked, defective barrel, missing or loose rubber gasket.".

• Brand Name: SYRINGE 5ML LL 21X1 BULK CONV PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9930399
• Report Number: 2243072-2020-00561
• Device Sequence Number: 2817465
• Product Code: FMF
• UDI-Device Identifier: 00382903030217
• UDI-Public: 00382903030217
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2020

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
• Operator of Device: Other
• Device Catalogue Number: 303021
• Device Lot Number: 7093007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 03/17/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/23/2020; 05/29/2020
• 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