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

Catalog Number 306572

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 12/16/2018

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8179538.Medical device expiration date: 2021-06-30.Device manufacture date: 2018-06-28.Medical device lot #: 8185572.Medical device expiration date: 2021-06-30.Device manufacture date: 2018-07-04.Medical device lot #: 8242797.Medical device expiration date: 2021-08-31.Device manufacture date: 2018-08-30.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe caused an unspecified number of allergic reactions which included breathlessness and swelling to both legs.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe caused an unspecified number of allergic reactions which included breathlessness and swelling to both legs.

Manufacturer Narrative

Investigation summary: dhr: 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.Conclusion(s): based on the information provided, it is more probable than not that the symptoms described may be an allergic reaction; however, it is highly improbable that this reaction was produced by the normal saline in the bd posiflush product.During the period 2017-2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction, apart from fresenius kabi uk.There are no known allergies to normal saline, either topical or within the body.It is most likely that whatever fluid was in the iv line prior to flushing contained inadequately flushed medication or glucose from previous treatments.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8329588
• MDR Text Key: 135851292
• Report Number: 9616657-2019-00121
• Device Sequence Number: 1
• Product Code: FMF
• 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

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other