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

Catalog Number 306546

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

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 bd posiflush¿ normal saline syringe was "leaking from the back end of seal when pressure was applied to the plunger¿.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: two samples were received for evaluation by one of our quality engineers.The two (2) samples received have no packaging flow wrap.They do have the plunger rod-rubber stopper, the tip cap and saline solution.The barrel label confirms the lot# 8050995.Pressure was put on the plunger rod not noticing any leakage; both samples were inspected finding no issues therefore failure mode is not verified and root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage past stopper with lot #8050995, regarding item #306546.There was no documentation of issues for the complaint of batch 8050995 during this production run.Investigation conclusion: unable to determine a root cause.

Event Description

It was reported that the bd posiflush¿ normal saline syringe was "leaking from the back end of seal when pressure was applied to the plunger¿.Found during use.No reports of serious injury or medical intervention noted.

Event Description

It was reported that the bd posiflush¿ normal saline syringe was "leaking from the back end of seal when pressure was applied to the plunger¿.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7630131
• MDR Text Key: 112296882
• Report Number: 1911916-2018-00312
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

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: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8050995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 05/31/2018
• Supplement Dates FDA Received: 07/17/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other