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

Catalog Number 306594

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2018

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.

Event Description

It was reported that before use, a bd posiflush¿ syringe was found with the barrel damaged when the unit package was opened.There was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation results: a photo was received in the columbus plant for evaluation.It shows a syringe with plunger rod-rubber stopper, tip cap, and saline solution.The barrel label confirms the lot#7114599.Dhr/bhr review: there were no issues for barrel flange damage documented during the production of this batch.All inspections were accepted during the production of this batch.There were no parts damaged documented.Conclusion: the flange is damaged therefore failure mode is verified.Root cause could not be determined.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7212552
• MDR Text Key: 98194440
• Report Number: 1911916-2018-00004
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7114599
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other