MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN; SHARPS DISPOSAL

Catalog Number 305093

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Oem manufacture: 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.

Event Description

It was reported that 6 sharps coll troly foot-op 19gl recykleen experienced product damage.The following information was provided by the initial reporter: material no: 305093, batch no: unknown.Per customer email: we received this (b)(4) for the 305093 carts (b)(6) 2019.We shipped them to our customer (b)(6) 2019.They have reported 6 of them has some damage.The need 6 caster with brakes for them.

Event Description

It was reported that 6 sharps coll troly foot-op 19gl recykleen experienced product damage.The following information was provided by the initial reporter: material no: 305093, batch no: unknown.Per customer email: we received this po 576444 for the 305093 carts 3/15/19.We shipped them to our customer 3/18/19.They have reported 6 of them has some damage.The need 6 caster with brakes for them.

Manufacturer Narrative

Investigation summary: the dhr review process was not performed due to the lot number was unknown.Based on the pictures provided from customer it can be seen an unassembled wheel (incomplete caster in the trolleys) therefore it means that caster were assembled during the manufacturing process ; the current process was reviewed in order to rule out an supplier issue in the casters (as raw material), they were found acceptable and without issues in the assembly.For this reason, a picture from the original packaging is needed in order to rule out a root cause due incorrect handling or damages in the packaging.Conclusion: based on this investigation it was not possible determine the root cause like a failure mode related to the manufacturing process because the evidence from original packaging is needed to determine the root cause of this issue.However, as per risk assessment result; a corrective action is needed therefore a capa record (car-jrz-00000109) was opened in order to perform an exhaustive investigation and to implement actions that helps to avoid or reduce occurrences related to this issue.

• Brand Name: SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN
• Type of Device: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8567036
• MDR Text Key: 145238807
• Report Number: 2243072-2019-00824
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305093
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other