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

Catalog Number 306594

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

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

Event Date 03/14/2018

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 before use a bd posiflush¿ syringe was found damaged as ¿nurse found flange damaged after opened plastic package.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

A photo and sample were available for evaluation.A quality engineer was able to review the photo and sample and found that there was barrel/flange damage in both thus verifying the reported issue.A possible root cause was determined to have been a variation with the plunger rod labeler.The equipment was inspected and any necessary adjustments were made.There were no quality notifications found during production of the reported batch.There was no documentation of issues for the complaint of batch 7230502 during this production run.Root cause could not be determined.It is possible the plunger rod labeler equipment experienced a variation; however, adjustments have been verified.Capa not required for this event.

• 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
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7355746
• MDR Text Key: 103277825
• Report Number: 1911916-2018-00113
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7230502
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other