MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306594

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

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¿ syringe flush joint was broken.The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient was admitted to the hospital at 17:49 on (b)(6) 2020 due to "brain contusion".Diagnosis: scalp laceration, transient ischemic attack? after the infusion is over at 23:00 on (b)(6) 2020, use the "flush" to seal the tube, the flush joint is broken, causing the blood vessel to return blood, immediately replace another one to reseal the tube, successfully complete the tube sealing.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 63188.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h.10.

Event Description

It was reported that the bd posiflush¿ syringe flush joint was broken.The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted to the hospital at 17:49 on (b)(6) 2020 due to "brain contusion".Diagnosis: 1.Scalp laceration 2.Transient ischemic attack after the infusion is over at 23:00 on (b)(6) 2020, use the "flush" to seal the tube, the flush joint is broken, causing the blood vessel to return blood, immediately replace another one to reseal the tube, successfully complete the tube sealing.".

• Brand Name: BD POSIFLUSH SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11121387
• MDR Text Key: 225324002
• Report Number: 1911916-2021-00002
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 306594
• Device Lot Number: 0063188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1