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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Edema (1820)

Event Date 01/01/2019

Event Type  Injury  

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 patient developed "oedema" in the ankles after the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had been used to "flush the line before and after each infusion".However, there was no medical intervention reported, and no further information regarding the patient's outcome has been received.As reported by the customer, "details: report received to advised oedema identified in patient ankles.No further information obtained on outcome of patients' condition.Product - 306572 pfs 0.9%p/flush xs saline 10ml st - use to flush line before and after each infusion.Batch:8242797.".

Event Description

It was reported that the patient developed "oedema" in the ankles after the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had been used to "flush the line before and after each infusion".However, there was no medical intervention reported, and no further information regarding the patient's outcome has been received.As reported by the customer, "details: report received to advised oedema identified in patient ankles.No further information obtained on outcome of patients' condition.Product: 306572 pfs 0.9%p/flush xs saline 10ml st - use to flush line before and after each infusion.Batch:8242797".

Manufacturer Narrative

H.6.Investigation summary: dhr: complaint trending review of the lot for this issue reveals this is the seventh complaint.The non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute to the complaint verbatim reported by the customer.No sample available.Conclusion(s): there is no evidence that posiflush syringe was responsible for this reaction.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.

• 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: 8387158
• MDR Text Key: 137726093
• Report Number: 9616657-2019-00132
• 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: 03/15/2019

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?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8242797
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other