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

Catalog Number 306594

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

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 the customer found the flange damaged when opening the unit package.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: a sample was received in the columbus plant for evaluation.The barrel label confirms the lot#7191751.It has the plunger rod-stopper, the tip cap and the saline solution.It has the barrel flange damaged therefore failure mode is verified.Dhr review shows there were no documentation of issues for the complaint of batch 7191751 during this production run.This is the first complaint to the batch 7191751 for the same defect or symptom.All our inspections performed while manufacturing this batch were accepted.No rejections were documented.There were no qns issued during the production of this batch listed in the complaint.Root cause could not be determined.Based on the above, no formal corrective action is necessary at this time.

• 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: 7232006
• MDR Text Key: 98787687
• Report Number: 1911916-2018-00012
• 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: 02/28/2018

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: 06/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7191751
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other