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

Catalog Number	305604
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as flextronics is an oem manufacturing site.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 prior to use the lids were discovered to be missing with 8 bd sharps coll slide close chemo 9gal.The following information was provided by the initial reporter: it was reported that the lids were missing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/18/2020.H.6.Investigation: it was reported lids missing.A sample and photo representation was provided for evaluation.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids for the reported lot number.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance for the same part number.This lot was confirmed produced after corrective actions.A weight system that provides a weighted label for each final box before shipment has already been implemented for this product to ensure the correct quantity of pieces per box before shipping.It was not possible to confirm that any failure mode was related to the manufacturing process with the information provided.There appears to have been a repackaging issue which occurred during distribution by the distributor, ¿henry schein¿.The actual root cause is unknown.Distributor control procedures to process and repackage containers and lids is unknown.Based on these findings, our investigation is inconclusive.
Event or Problem Description
It was reported that prior to use the lids were discovered to be missing with 8 bd sharps coll slide close chemo 9gal.The following information was provided by the initial reporter: it was reported that the lids were missing.

• Brand Name: BD 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: 10370373
• Report Number: 2243072-2020-01194
• Device Sequence Number: 14370522
• Product Code: FMI
• UDI-Device Identifier: 50382903056045
• UDI-Public: 50382903056045
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (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): 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: 0102914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• 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