MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH PRE-FILLED SALINE; SALINE FLUSH

Catalog Number 306594

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

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 the nurse found flange of the bd posiflush pre-filled saline syringe damaged after opening the plastic package.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update mar 19, 2019.Three (3) samples were received.All are with no packaging flow wrap; all three (3) have the tip cap, the plunger rod- rubber stopper and saline solution; the barrel label confirms the lot# 7165927.All of them have the barrel flange damaged.Product within specification? yes no.Dhr/bhr review: there were no documented issues for the complaint of batch 7165927 during this production run.Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There was no issue documented about barrel flange damaged.Root cause.The plunger rod labeler equipment possible experienced a variation; anyway, adjustments have been verified.

• Brand Name: BD POSIFLUSH PRE-FILLED SALINE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7350800
• MDR Text Key: 103007027
• Report Number: 1911916-2018-00106
• 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: 03/20/2018

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?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7165927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other