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

Catalog Number	305613
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacture: 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.
Event or Problem Description
It was reported that an unspecified number of sharps coll chemo 19gal yellow experienced missing lids.The following information was provided by the initial reporter: material no: 305613, batch no: 9018920.It was reported that the lids are missing.
Additional Manufacturer Narrative
Investigation: it was reported that lids were missing.No sample photo representation was provided for evaluation.No photo of the original packaging was provided, and the number of missing lids was not confirmed.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance reported for missing lids 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 since the weight system is validated and did not detect any missing components.There may have potentially been a repackaging issue which occurred during distribution.The actual root cause is unknown.
Event or Problem Description
It was reported that an unspecified number of sharps coll chemo 19gal yellow experienced missing lids.The following information was provided by the initial reporter: material no: 305613.Batch no: 9018920.It was reported that the lids are missing.

• Brand Name: SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8575551
• Report Number: 2243072-2019-00842
• Device Sequence Number: 16603356
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305613
• Device Lot Number: 9018920
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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