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

Model Number	305160
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the sharps coll 6gal red small open cap lid was broken.The following information was provided by the initial reporter, translated from (b)(6) to english: "the lid was found to be broken on arrival of the product.".
Additional Manufacturer Narrative
H.6.Investigation: the dhr review was not performed due to the lot number was not provided by customer.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken issue for the same part number throughout the last twelve months.According with this investigation there is not enough information provided from customer like a picture of the original packaging in order to rule out that this product was damaged by incorrect handling, transportation or because a not suitable packaging was used (product repackaged within the distributor).
Event or Problem Description
It was reported that the sharps coll 6gal red small open cap lid was broken.The following information was provided by the initial reporter, translated from japanese to english: "the lid was found to be broken on arrival of the product.".

• Brand Name: 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: 11061542
• Report Number: 2243072-2020-02120
• Device Sequence Number: 19552320
• 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): 01/04/2021

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: 305160
• Device Catalogue Number: 305160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1