MAUDE Adverse Event Report: BECTON DICKINSON BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET

Catalog Number	305604
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	05/01/2019
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), nj has been listed and the (b)(4) 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.
Event or Problem Description
It was reported that the bd¿ chemotherapy sharps collector slide top with gasket lid was found cracked before use.The following information was provided by the initial reporter, translated from (b)(4) to english: "before use, the lid was cracked.".
Additional Manufacturer Narrative
H.6.Investigation: 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 be performed due to the lot number was unknown.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid cracked for the same part number throughout the last twelve months.According with this investigation there is no enough information provided from customer like a picture from the original packaging to determine the root cause of this non-conformance.Additionally, a review of the dhrs for the last five lots (9136972, 9138962, 9139917, 9140924, and 9141961) manufactured for the part number 305604 was performed; the result doesn¿t showed issues like ncmr¿s during the manufacturing process.
Event or Problem Description
It was reported that the bd¿ chemotherapy sharps collector slide top with gasket lid was found cracked before use.The following information was provided by the initial reporter, translated from japanese to english: "before use, the lid was cracked.".

• Brand Name: BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8616518
• Report Number: 2243072-2019-00937
• Device Sequence Number: 291592
• Product Code: FMI
• UDI-Device Identifier: 50382903056045
• UDI-Public: 50382903056045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943140
• 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): 06/21/2019

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: 305604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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