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

Model Number	305551
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the sharps coll next gen 5.4qt clear 20/pack lid was found damaged.The following information was provided by the initial reporter, translated from (b)(6) to english: "according to the customer's report, a lid component was found to be damaged.".
Event or Problem Description
It was reported that the sharps coll next gen 5.4qt clear 20/pack lid was found damaged.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, a lid component was found to be damaged.".
Additional Manufacturer Narrative
H.6.Investigation: according to the dhr review process, the result showed there were no issues reported like damaged lid during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like damaged lid issue for the same part number throughout the last twelve months.According with this investigation and the information provided from the customer it could be seen the following: lot number 0039911 could be seen.The door is broken where the pin should be assembled with the top.As part of this investigation it was noticed that this issue arose from a product sold in japan that¿s why the evidence of the packaging used will be needed to determined the root cause, because in accordance to previous information provided by customer all product sold to japan is being repackaged.Therefore, due to lack of evidence it can¿t be confirmed this nonconformance as a failure mode related to a manufacturing process, because this kind of damages could be generated due to different variables like transit damaged, inadequate packaging to send the product to the end user.H3 other text : see h.10.

• 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: 11276777
• Report Number: 2243072-2021-00220
• Device Sequence Number: 2590632
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: 00382903055517
• 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): 02/24/2021

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: 305551
• Device Catalogue Number: 305551
• Device Lot Number: 0039911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1