MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLL 6GAL RED SMALL OPEN CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305160
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd¿ sharps coll 6gal red small open cap lid was chipped.This was discovered before use.The following information was provided by the initial reporter: the corner of the lid was chipped.
Event or Problem Description
It was reported that bd¿ sharps coll 6gal red small open cap lid was chipped.This was discovered before use.The following information was provided by the initial reporter: the corner of the lid was chipped.
Additional Manufacturer Narrative
Investigation summary: no samples or pictures were received.Three attempts to get more information or pictures were made, however in none of the cases additional information were provided.The dhr review process was not able to perform due to the lot number was unknown.Conclusion: based on information provided it was not possible determine the root cause like a failure mode related to the manufacturing process because there is no enough information like a picture of the original packaging to perform an exhaustive investigation.

• Brand Name: BD¿ SHARPS COLL 6GAL RED SMALL OPEN CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8776078
• Report Number: 2243072-2019-01367
• Device Sequence Number: 2374865
• Product Code: FMI
• UDI-Device Identifier: 50382903051606
• UDI-Public: 50382903051606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112774
• 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): 08/12/2019

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 Catalogue Number: 305160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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