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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: 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.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 sharps coll slide close chemo 9gal experienced a missing absorbing pad.The following information was provided by the initial reporter: according to the customer's report, there was no absorbent pad.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received.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 missing absorbent pad for the same part number throughout the last twelve months.According with this investigation and information provided by the customer it was possible to determine the non-conformance missing absorbing pad as an issue related to a manufacturing process because the absorbent pad it¿s attached by the manufacturing personnel and there¿s no extra-handling that could cause the issue and also has been reported in previous complaints.Due the lot number was not provided it was not possible to determine if the product was manufactured prior the improvement actions.
Event or Problem Description
It was reported that the sharps coll slide close chemo 9gal experienced a missing absorbing pad.The following information was provided by the initial reporter: according to the customer's report, there was no absorbent pad.

• 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: 11586710
• Report Number: 2243072-2021-00898
• Device Sequence Number: 16883019
• 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
• Serviced by Third Party (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): 04/16/2021

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: Lay User/Patient
• Device Model Number: 305604
• Device Catalogue Number: 305604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1