MAUDE Adverse Event Report: BECTON DICKINSON BD¿ NEXT GENERATION SHARPS COLLECTOR YELLOW

Catalog Number 301272

Device Problem Defective Component (2292)

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

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd¿ next generation sharps collector yellow there was an issue with faulty lids.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the bd next generation sharps collector yellow there was an issue with faulty lids.There was no report of injury or medical intervention.

Manufacturer Narrative

No samples or pictures were received.Three attempts to get more information or pictures were made, however in none of the cases additional information were provided.According to the dhr review process; the result showed there were no issues reported like lid will not shut during the manufacturing process of the lot number reported under this customer complaint.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.According with this investigation, there is no enough information to perform an exhaustive investigation since no samples or pictures to understand this failure mode were provided from customer.As part of this investigation the current process was evaluated in order to rule out that this issue could be omitted by error as well to review the inspection controls established within the manufacturing process, the result showed that there is a 100% visual inspection performed by production department.Also, a visual and functional inspection based on aql sampling plan is performed by a quality auditor.Additionally, a review of the customer complaint records was performed; in accordance with the cc¿s records, no additional complaints were received through the last twelve months for the same part number and issue.According to risk assessment 11 occurrences (pieces) has been notified of 4222649 pieces sold throughout last twelve months (11/4222649= 0.0000026), with this occurrence result and severity level s3 (severity based on pfmea) this failure mode was considered low risk, since it was less than the one defined on the risk assessment threshold (likelihood of occurrence between 1 in a 100000 to 1 in 1000000).Incorrect lid (a picture from the original packaging is needed to rule out that was generated due to a repackaging process).Damaged lid (a picture from the original packaging is needed to rule out that was generated due to transit damages and/or incorrect handling).Root cause unknown.

• Brand Name: BD¿ NEXT GENERATION SHARPS COLLECTOR YELLOW
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7910014
• MDR Text Key: 121861659
• Report Number: 2243072-2018-01382
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301272
• Device Lot Number: 8014922
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other