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

Catalog Number 306594

Device Problems Device Damaged Prior to Use (2284); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

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 before use of the bd posiflush¿ syringe customer found the plunger rod damaged when unit package was opened.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: a sample was received in the (b)(4) plant for evaluation.It has the plunger rod, rubber stopper, the tip cap and the saline solution is up the 3ml mark.The barrel label confirms the lot#7184857.It has the barrel flange damaged therefore failure mode is verified.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.Dhr review shows all inspections and testing were accepted during the production of this batch.Based on the investigation no capa is required for this event.

• 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: 7280262
• MDR Text Key: 100556610
• Report Number: 1911916-2018-00042
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7184857
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other