MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305551
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	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that sharps coll next gen 5.4qt clear 20/pack had a part of the lid missing.The following information was provided by the initial reporter: "a part of the lid was missing.".
Additional Manufacturer Narrative
H.6 investigation summary: a dhr review was no able to be performed due to the lot number was unknown.A sample was provided.Based on the samples it was confirmed the following: the internal door of the lid was not assembled.In accordance with the review of the customer complaint records it was found that there were not complaints reported for the same issue and part number during the last twelve months.The current process was reviewed and was found that the assembly work instructions were followed properly as described.Also, a second inspection is made by quality inspector based on aql sampling plan.Within the current process, a weighing system was installed as part of the corrective actions #ca-rj001301 initiated due to high occurrence of missing lids issue reported in customer complaints and internal ncmr¿s.The system is capable to detect when a lid is missing in the box however, the system has not the capacity to detect when a door was not assembled within the lid.According to risk assessment 1 occurrences (pieces) has been notified of (b)(4) pieces sold throughout last twelve months ((b)(4)), with this occurrence result and severity level s2 (severity based on pfmea) this failure mode was considered low risk, since it was less than the one defined on the risk assessment threshold (likelihood of occurrence of less than 1 in 1000000).The root cause has been found to be assembly omission.
Event or Problem Description
It was reported that sharps coll next gen 5.4qt clear 20/pack had a part of the lid missing.The following information was provided by the initial reporter: "a part of the lid was missing.".

• Brand Name: SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9733009
• Report Number: 2243072-2020-00245
• Device Sequence Number: 13638536
• Product Code: FMI
• UDI-Device Identifier: 50382903055512
• UDI-Public: 50382903055512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943141
• 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): 03/04/2020

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: 305551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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