MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE CHEMO 9GAL; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305604
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that sharps coll slide close chemo 9gal was missing the absorbent pad.This was discovered before use.The following information was provided by the initial reporter: during inspection at a hospital department, it was found that there was no absorbent pad.
Event or Problem Description
It was reported that sharps coll slide close chemo 9gal was missing the absorbent pad.This was discovered before use.The following information was provided by the initial reporter: during inspection at a hospital department, it was found that there was no absorbent pad.
Additional Manufacturer Narrative
H.6.Investigation: 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.As part of this investigation with the evidence provided by the customer, the following can be seen: 1.The missing absorbing pad can be seen.2.The lot number (0017923) can be confirmed.According with this investigation this failure mode had been already identified as part of previous customer complaint as per the previous investigation result it was noticed that the failure mode has been considered like a manufacturing process issue, because the absorbent pad it¿s attached by the manufacturing personnel and there¿s no extra-handling that could cause the issue.

• Brand Name: SHARPS COLL SLIDE CLOSE CHEMO 9GAL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10515706
• Report Number: 2243072-2020-01388
• Device Sequence Number: 19669331
• Product Code: FMI
• UDI-Device Identifier: 00382903056040
• UDI-Public: 00382903056040
• 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): 10/29/2020

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 Model Number: 305604
• Device Catalogue Number: 305604
• Device Lot Number: 0017923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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