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

Catalog Number 306595

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd posiflush¿ normal saline syringe was broken while still in the plastic package.The product was not used and there was no report of injury or medical interventions.

Manufacturer Narrative

Investigation summary: three samples were received for evaluation.All of them have the sealed packaging flow wrap, the plunger rod-rubber stopper, the tip cap and saline solution.The barrel labels confirm the lot# 7208540.All three have the barrel flange damaged therefore failure mode is verified.Possible root cause is that the plunger rod labeler equipment possibly experienced a variation however this could not be determined as there were no quality notification issued during the production of this batch listed in the complaint and all inspections were accepted during the production of this batch.A device history review indicated that there was no documentation of issues for the complaint of batch 7208540 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.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7491661
• MDR Text Key: 107619371
• Report Number: 1911916-2018-00222
• Device Sequence Number: 1
• Product Code: NGT
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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: 07/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7208540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other