MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 19GAL GASKET RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305666
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(4).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.
Event or Problem Description
It was reported that sharps coll 19gal gasket red lid was missing.The following information was provided by the initial reporter: it was reported by the distributor that the lids are missing.
Event or Problem Description
It was reported that sharps coll 19gal gasket red lid was missing.The following information was provided by the initial reporter: it was reported by the distributor that the lids are missing.
Additional Manufacturer Narrative
H6: investigation summary a sample was received and investigated with the customer's complaint of missing lids.There were no lids in the received sample and it was then shipped to flex (the supplier) for further investigation.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process of the lot number 0331926 reported under this customer complaint.A review of the ncmr¿s (non-conformant material reports) was performed; the result showed there were no issues reported like missing lids issue for the same part number throughout the last twelve months.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there is not enough information like method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility.The controls were verified within the manufacturing process and confirmed as capable to detect the lack of missing lids.Potential root cause 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non controlled handling within distributor facilities.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SHARPS COLL 19GAL GASKET RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12079174
• Report Number: 2243072-2021-01763
• Device Sequence Number: 3411822
• Product Code: FMI
• UDI-Device Identifier: 00382903056668
• UDI-Public: 00382903056668
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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 Catalogue Number: 305666
• Device Lot Number: 0331926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1