MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLL 5GAL RED 1103 VENTED CAP; SHARPS DISPOSAL

Catalog Number	305491
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Date of event: unknown.Medical device expiration date: n/a.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 bd¿ sharps coll 5gal red 1103 vented cap was locked and could not be opened.Customer¿s verbatim: ¿locked can't open.¿.
Event or Problem Description
It was reported that bd¿ sharps coll 5gal red 1103 vented cap was locked and could not be opened.Customer¿s verbatim: ¿ locked can't open.¿.
Additional Manufacturer Narrative
H.6.Investigation: a sample was provided for investigation.A compliant review was performed by the supplier.A cap locked shut was reported, and the cap should not be locked.In stock product was checked and the complaint was reviewed with all personnel.No issues were found.A total of 1776 pieces were reworked and evaluated with no issue found.No stock found with locked caps.No corrective action was required.The investigation could not determine a root cause and was inconclusive.

• Brand Name: BD¿ SHARPS COLL 5GAL RED 1103 VENTED CAP
• Common Device Name: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8441304
• Report Number: 2243072-2019-00543
• Device Sequence Number: 3014210
• Product Code: FMI
• UDI-Device Identifier: 50382903054911
• UDI-Public: 50382903054911
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• 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): 05/29/2019

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: 305491
• Device Lot Number: 8149001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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