MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 14QT RED 1508 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305464
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.The date received by manufacturer has been used for this field.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 one of the lid corners wouldn't "snap on tight" to the sharps coll 14qt red 1508 non-vent cap before use, making it so the cover came off "easier than usual".The following information was provided by the initial reporter: "it seems that one of the corners does not snap on tight making the cover come off easier than usual.In the past, once they were closed it was impossible to reopen them.".
Event or Problem Description
It was reported that one of the lid corners wouldn't "snap on tight" to the sharps coll 14qt red 1508 non-vent cap before use, making it so the cover came off "easier than usual".The following information was provided by the initial reporter: "it seems that one of the corners does not snap on tight making the cover come off easier than usual.In the past, once they were closed it was impossible to reopen them.".
Additional Manufacturer Narrative
H.6.Investigation: the actual product nor photo representation was received.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to the reported incident, ¿lid does not close tight¿.The current manufacturing process was reviewed with no issues found.Based on the information available, our investigation is inconclusive, and the actual root cause is unknown.

• Brand Name: SHARPS COLL 14QT RED 1508 NON-VENT CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9956112
• Report Number: 2243072-2020-00605
• Device Sequence Number: 11732988
• Product Code: FMI
• UDI-Device Identifier: 50382903054645
• UDI-Public: 50382903054645
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• 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): 04/24/2020

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: 305464
• Device Lot Number: 9164944
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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