MAUDE Adverse Event Report: BECTON DICKINSON BD CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305604
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2020
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 (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.
Event or Problem Description
It was reported that the bd¿ chemotherapy sharps collector slide top with gasket was missing the absorbing pad prior to use.The following information was provided by the initial reporter, translated from (b)(4) to english: "during inspection at spd, it was found that there was no absorbent pad.".
Additional Manufacturer Narrative
H.6.Investigation: no samples or photos were received.Three attempts to get more information or pictures were made, however in none of the cases additional information were provided.According to the dhr review process; the result showed there were no issues reported like missing absorbent pad 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 missing absorbent pad for the same part number throughout the last twelve months.Based on this investigation this failure mode has been considered like a manufacturing process issue because the absorbent pad is attached by the manufacturing personnel and there¿s no extra-handling that could cause the issue.Containment action as a quality alert was implemented within the manufacturing process to prevent that this issue is not omitted during the assembly process.
Event or Problem Description
It was reported that the bd¿ chemotherapy sharps collector slide top with gasket was missing the absorbing pad prior to use.The following information was provided by the initial reporter, translated from japanese to english: "during inspection at spd, it was found that there was no absorbent pad.".

• Brand Name: BD CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10370356
• Report Number: 2243072-2020-01193
• Device Sequence Number: 19750857
• 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): 09/02/2020

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 Catalogue Number: 305604
• Device Lot Number: 9353914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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