MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE WITH BD TWINPAK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303391
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
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
It was reported that an unspecified number of bd 3ml syringe with bd twinpak experienced device damage/deformation with the device still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 303391 batch no: 9101699.Event description: quantity affected: 1 bx.Reported issue: about 30 of the syringes had the needle broken off in the pack.
Additional Manufacturer Narrative
Investigation summary: ten 3ml twinkpak syringes with needle assemblies in blister packs from batch 9101699 (p/n 303391) were received and evaluated.Nine of the packages were fully sealed one was opened.It was observed all the syringes contained broken or cracked hubs and deformations in the packaging consistent with the location of the hub.One of the packages was punctured creating a hole through the top web.The hub damage and open seal were rejectable per product specification.Machine logs indicate there were issues with the loading robot during the manufacture of this batch.Potential root cause for the damaged hubs and open seal defects are associated with the packaging process.It is possible when the loading robot was malfunctioning, the blister packs were loaded upright.Then, they were mechanically packed into the box and inadvertently crushed, which caused them to break and puncture one of the packs.The loading robot was reported to be repaired as of 5/30/2019 and was verified to be in proper working condition on 10/16/2019.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
It was reported that an unspecified number of bd 3ml syringe with bd twinpak experienced device damage/deformation with the device still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 303391, batch no: 9101699.Event description: quantity affected: 1 bx.Reported issue: about 30 of the syringes had the needle broken off in the pack.

• Brand Name: BD 3ML SYRINGE WITH BD TWINPAK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9042598
• Report Number: 1213809-2019-00927
• Device Sequence Number: 2352210
• Product Code: FMI
• UDI-Device Identifier: 30382903033912
• UDI-Public: 30382903033912
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 03/31/2024
• Device Catalogue Number: 303391
• Device Lot Number: 9101699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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