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

Catalog Number 306572

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced a damaged or open unit package/seal where sterility was compromised.The following information was provided by the initial reporter: patient reports on one posiflush the seal on the side of the packaging was broken and there seemed to be slight flecks of dirt (perhaps printer ink, patient reports it looked as if there had been a problem with the printer, there was a smudged line the length of the packaging).The other syringes in the pack seemed fine.Patient reports a second posiflush with a bit of smudged ink on the packaging.It was less than the previous one, the seal was not broken and it looked clean inside.But when opened a tiny fleck of dirt fell onto the sterile field, so the patient discarded that flush.Patient did not use either of the posiflush.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced a damaged or open unit package/seal where sterility was compromised.The following information was provided by the initial reporter: patient reports on one posiflush the seal on the side of the packaging was broken and there seemed to be slight flecks of dirt (perhaps printer ink, patient reports it looked as if there had been a problem with the printer, there was a smudged line the length of the packaging).The other syringes in the pack seemed fine.Patient reports a second posiflush with a bit of smudged ink on the packaging.It was less than the previous one, the seal was not broken and it looked clean inside - but when opened a tiny fleck of dirt fell onto the sterile field, so the patient discarded that flush.Patient did not use either of the posiflush.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-14.Investigation summary: a device history review was conducted for lot number 0251339.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.To aid in the investigation of this issue, samples were returned for evaluation by our quality engineer team.Through examination of the samples, both foreign matter and package damage were observed.It is possible that this incident resulted from jams within the mutlivac machinery.These jams could have produced contamination within the manufacturing area due to material catching within the machinery chains.Upon identification of the machinery jams, the issue was resolved.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 11135349
• MDR Text Key: 228935383
• Report Number: 9616657-2021-00002
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0251339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1