MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 6GAL RED 1103 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305457
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that sharps coll 6gal red 1103 non-vent cap had a broken lid.This occurred on 4 occasions.The following information was provided by the initial reporter: material no: 305457 batch no: 9167919.It was reported that they got 4 sharp containers with broken lids.
Event or Problem Description
It was reported that sharps coll 6gal red 1103 non-vent cap had a broken lid.This occurred on 4 occasions.The following information was provided by the initial reporter: material no: 305457 batch no: 9167919.It was reported that they got 4 sharp containers with broken lids.
Additional Manufacturer Narrative
Investigation summary no photos or sample representation was provided for the complaint.A dhr review was performed and showed there were no issues reported like broken lids during the manufacturing process of the lot number 9167919.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for lid broken for the same part number.According with this investigation there is not enough information provided from customer like a picture of the original packaging to rule out that this product could be damaged by incorrect handling, transportation or because a not suitable packaging was used (product repackaged within the distributor).It was concluded that due to the lack of information is not possible to determine this issue as failure mode related to the manufacturing process.Root cause is unknown due to lack of information.H3 other text : see h10.

• Brand Name: SHARPS COLL 6GAL RED 1103 NON-VENT CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11369996
• Report Number: 2243072-2021-00584
• Device Sequence Number: 3742796
• Product Code: FMI
• UDI-Device Identifier: 00382903054572
• UDI-Public: 00382903054572
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305457
• Device Catalogue Number: 305457
• Device Lot Number: 9167919
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1