MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 17L YELLOW; SHARPS COLLECTOR

Catalog Number 303209

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2020

Event Type  malfunction  

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.Medical device expiration date: na.Investigation summary: retain samples of the two noted production batches were reviewed and found to conform to cap application and pull off forces.This indicates no concern during the manufacture of the container from a dimensional point of view.It is most probably (without further relevant information) that the cap/closure was not effectively applied by the line operator during the secondary application process causing it to "detach" as advised.The application process has been reviewed and found to be effective in its application.Random audit of the process and feedback has been sought for any concerns that may be identified that may require correction.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned, and retained samples were found to conform to specification.Root cause description: supplier (b)(4).Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that 2 sharps coll 17l yellow lids detached from their collectors before use.The following information was provided by the initial reporter: "detaching lids.".

• Brand Name: SHARPS COLL 17L YELLOW
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10052330
• MDR Text Key: 195266682
• Report Number: 2243072-2020-00764
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2020

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
• Device Operator: Other
• Device Catalogue Number: 303209
• Device Lot Number: 19197006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other