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

Catalog Number 306572

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0126426 medical device expiration date: 2023-04-30 device manufacture date: 2020-05-05 medical device lot #: 01267451 was reported, however, this is not lot# manufactured by bd." a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that after use with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9% white foreign matter was discovered in tube.The following information was provided by the initial reporter, translated from french to english: 19/08 at 17:00; laying of a picc line perfusion on picc line on 19/08: 1 litre nacl 0, 9% started at 5.18pm + pantoprawole 40mg iv at 7.16pm.(b)(6) morning; appearance of white particles in pre-filled nacl syringes when rinsing the piccline for sampling.White particles also present in the sample tube.(on photo= particle at the level of coagulated blood) - syringe not conserved.Perfusion on piccline on (b)(6); 1 litre nacl 0.9% started at 15h30+ pantoprazale 40mg iv at 19h44 (b)(6) morning; test a new sample = whitish deposits in the syringe.A 2nd photo taken several hours after sampling - particle less visible on the photo- visually observing a larger deposit than the day before.Syringe kept batch 0126426- references other dms used: infusion set ref.Infusion set 1fl25 ( gel: 760070) nacl 0,9% 1litre : lot 19j07h and 20b054 ( gef: 521535) reference pantoprazole iv 40mg : lot not kept several in stock additionally, on 2020-08-31 the bd sales consultant provided the following additional information: could you please describe the action taken following this incident? quarantined batch of syringes.What were the consequences on your operation? did not concern a surgical operation but a sample, nothing to add, sample taken and results transmitted.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/14/2020.H.6.Investigation: a device history record review was performed for provided lot numbers 0126426 and 0167451 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.One physical sample belonging to lot number 0126426 was returned and through examination of the sample, the syringe was observed contaminated with blood.Five samples were returned for lot number 0167451.Two of the samples contained blood and the remaining three samples appeared free of any foreign contaminates within the saline.Based on the investigation results, the reported incident could not be substantiated and an exact cause could not be determined.Through examination of the samples and the provided information, it is possible that misuse of the product occurred.The posiflush syringes are pre-filled single use syringes intended for flushing only.Pre-filled and conventional syringes have different purposes.

Event Description

It was reported that after use with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9% white foreign matter was discovered in tube.The following information was provided by the initial reporter, translated from french to english: 19/08 at 17:00; laying of a picc line perfusion on picc line on 19/08: 1 litre naci 0, 9% started at 5.18pm + pantoprawole 40mg iv at 7.16pm.20/08 morning; appearance of white particles in pre-filled nacl syringes when rinsing the piccline for sampling.White particles also present in the sample tube.( on photo= particle at the level of coagulated blood) - syringe not conserved.Perfusion on piccline on 20/08; 1 litre nacl 0.9% started at 15h30+ pantoprazale 40mg iv at 19h44 21/08 morning; test a new sample = whitish deposits in the syringe.A 2nd photo taken several hours after sampling - particle less visible on the photo- visually observing a larger deposit than the day before.Syringe kept batch 0126426- references other dms used: infusion set ref.Infusion set 1fl25 ( gel: 760070) -nacl 0,9% 1litre : lot 19j07h and 20b054 ( gef: 521535) reference pantoprazole iv 40mg : lot not kept several in stock additionally, on 2020-08-31 the bd sales consultant provided the following additional information: - could you please describe the action taken following this incident? quarantined batch of syringes - what were the consequences on your operation? did not concern a surgical operation but a sample, nothing to add, sample taken and results transmitted.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10547837
• MDR Text Key: 216391883
• Report Number: 9616657-2020-00152
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other