MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE

Catalog Number 306572

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

(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 that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% blister packaging had poor perforation that caused it to open during the kit assembly before use.The following information was provided by the initial reporter: "1 blister opened during the kit assembly caused by the not well defined pre-cut 2 spot on the blister.".

Manufacturer Narrative

H.6.Investigation summary: the returned photos were reviewed and confirm the presence of spots on the blister.The non-conformances were reviewed for this batch; there were no non-conformances associated with this defect for this batch.The root cause of this complaint is associated with the multivac machine in the assembly process.This is an isolated incident, however the cleaning schedule is under review.A photo was received for examination.The photos were inspected and the photo sample confirms the presence of poor perforation.A device history was also conducted, which showed no non-conformances.The root cause was determined to be associated with the perforation stage of the manufacturing process.The blade maintenance program is currently under review.The intention is to decrease the time frame between blade replacements, therefore preventing poor perforation in the blister packs.Bd will continue to track and trend these reported issues.H3 other text : see section h.10.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% blister packaging had poor perforation that caused it to open during the kit assembly before use.The following information was provided by the initial reporter: "1 blister opened during the kit assembly caused by the not well defined pre-cut 2 spot on the blister".

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8695834
• MDR Text Key: 156955850
• Report Number: 9616657-2019-00232
• Device Sequence Number: 1
• Product Code: NGT
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9074905
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other