MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML LL TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number 309703

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in.And the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Initial reporter phone#: direct: (b)(6)| mobile: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that syringe 5ml ll tip bulk convenience pak came with a mix of product types.This occurred on 5 occasions.The following information was provided by the initial reporter: it was reported that 3ml packages were mixed in with 5ml packages, and the lot numbers were the same as the 3ml.Verbatim: two issues raised here: pharmacy tray labeled as 309703 (5ml) but has 3ml syringe packed inside it.In the same one packing case, some pharmacy trays are 3ml of item code 309702, while other pharmacy trays are 5ml of item code 309703.Those are correctly labelled on trays but comingled in packing case.Another wired thing is that those two different item codes share the same lot number.

Event Description

It was reported that syringe 5ml ll tip bulk convenience pak came with a mix of product types.This occurred on 5 occasions.The following information was provided by the initial reporter: it was reported that 3ml packages were mixed in with 5ml packages, and the lot numbers were the same as the 3ml.Verbatim: two issues raised here: 1.Pharmacy tray labeled as 309703 (5ml) but has 3ml syringe packed inside it.2.In the same one packing case, some pharmacy trays are 3ml of item code 309702, while other pharmacy trays are 5ml of item code 309703.Those are correctly labelled on trays but comingled in packing case.Another wired thing is that those two different item codes share the same lot number.

Manufacturer Narrative

H6: investigation summary: bd received 1 shipper submitted for evaluation.The reported issue was confirmed upon inspection of the shipper.All the 12 trays within the shipper had 3ml syringes inside the trays instead of just 5ml syringes.A root cause can be linked to the packaging process.The 5ml and 3ml syringes have similar dimensions and manufacturing personal mistakenly placed the incorrect syringe into the trays.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.A quality alert was generated and all manufacturing personal involved with the process have been notified of the error.Similar products have been segregated to different areas to prevent the improper packaging of materials.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12467344
• MDR Text Key: 271263360
• Report Number: 2243072-2021-02306
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903097036
• UDI-Public: 00382903097036
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1