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

Catalog Number 306574

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The reported lot # does not exist for the reported cat #.Therefore, the device manufacture and expiration dates are unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.No samples or photos were received in the columbus plant for evaluation.This is the first complaint for lot# 7076670 for the same defect or symptom.There was no documentation of the issue identified in the complaint during this production run for batch 7076670.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 were no voids/ bubbles on molded parts and missing barrel label issues documented.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.The investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.

Event Description

"it was reported before use of the 5 ml bd posiflush¿ sp it was noted that one contained a large air bubble and the other had no labeling on it¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Bd received a sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for missing label with the incident lot was observed.There were no voids/ bubbles on molded parts.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD POSIFLUSH¿ SP
• 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: 7060066
• MDR Text Key: 93822414
• Report Number: 1911916-2017-00312
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011982
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306574
• Device Lot Number: 7076670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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