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

Catalog Number 306595

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2018

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 during use a bd posiflush¿ normal saline syringe was found leaking as ¿nurse found leakage from plunger rod when carried out the exhaust operation.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: dhr review: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.A sample was received.It came with no packaging flow wrap and no tip cap.It is wrapped in a transparent plastic glove.It has the plunger rod-rubber stopper and saline solution up to the 3ml mark.The barrel label confirms the lot#7173519.The sample didn¿t show leakage past stopper when tried to simulate the failure; however a 1¿ long crack on the barrel wall was noticed.It is towards the top part of the syringe from about the 6ml mark to the 10ml mark.Product within specification? ¿ yes ¿ no 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 leakage past stopper.Possible root cause is the barrel wall cracked.Possible through the crack the saline solution went over the stopper while pulling up the plunger rod-rubber stopper.

• 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: 7359377
• MDR Text Key: 103291842
• Report Number: 1911916-2018-00117
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7173519
• Date Manufacturer Received: 03/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other