MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ SHARPS COLLECTORS

Catalog Number 305072

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(4) has been listed and (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: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the lids of multiple unspecified bd¿ sharps containers would not close.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Additional information: customer updated the product information.Brand name has been updated: bd recykleen¿ sharps collectors.Catalog number has been updated, 305072.Lot number has been updated, 0293266.Udi number has been updated, (b)(4).Manufacture date has been updated, 10/20/2010.Medical device expiration date: n/a 510k number has been updated, n/a.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.

Manufacturer Narrative

Investigation summary: according to picture provided from customer an incorrect assembly is noted due to a label was added on the slider door which could be causing an incorrect functionality because the pin observed in the picture should be assembled into the slot showed on the slider picture.Also, the sharps collector could be being reused because on the top it can be seen a cut, this cut is needed to get open the collector.Dhr review and ncmr review were not performed since the lot and part number were unknown.New evaluation request with part number and lot number provided sent to supplier dhr/ncmr review a review of the dhr was performed; in according with flex records, the lot number 0293266 was considered unknown within flex facilities.The lot number is constructed with a specific nomenclature in where every digit has a specific meaning, the first digit: manufacturing year, next 3 digits: julian day, fifth digit is used to indicate the manufacturing facility, in this case the number ¿9¿ is used to identify flex manufacturing facility, therefore it means that this collector wasn¿t manufactured in flex facility.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid will not shut for the same part number throughout the last twelve months.Investigation conclusion: according to this investigation result, the root cause is considered unknown since the product could be being misused however the sample is needed to evaluate the functionality as well to determine the root cause.

Event Description

It was reported that the lids of multiple unspecified bd¿ sharps containers would not close.There was no report of exposure, injury or medical intervention.

• Brand Name: BD RECYKLEEN¿ SHARPS COLLECTORS
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7494272
• MDR Text Key: 107721469
• Report Number: 2243072-2018-00280
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305072
• Device Lot Number: 0293266
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other