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

Catalog Number 306574

Device Problem Filling Problem (1233)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).Summary: two samples were returned to bd for evaluation.A quality engineer was able to inspect the samples and found that the saline solution was underfilled thus verifying the reported issue.The saline solution was found to be at the 2.5ml mark and should've been at the 5ml mark.There was most likely an issue with these being detected during process inspections.A device history review was performed on the reported batch and revealed that all checks were under the aql complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Conclusion: dhr/bhr review.There is documentation for low fill volume being found twice during plunger rod qc checks on october 8, 2017.An aql of 0.25% was performed each time and both checks passed.Investigation comments: dhr/bhr review.There is documentation for low fill volume being found twice during plunger rod qc checks on (b)(6) 2017.An aql of 0.25% was performed each time and both checks passed.Investigation comments: all our inspections performed while manufacturing this batch were accepted; there were two instances where low fill volume was detected; stat sampling was performed and passed.Update may 1, 2018.Two (2) samples were received.They have no packaging flow wrap, they have the tip cap, plunger rod-rubber stopper and saline solution.The barrel labels confirm the lot#7264801.The saline solution is up to the 2.5ml mark; this is 5ml syringe.Product within specification? yes? no? capa not required for this event.Root cause: possible root cause could be product with low fill volume may have made it through to packaging.Update may 1, 2018.Possible root cause.An escape when the low fill volume was detected in the process inspections.

Event Description

It was reported a 5ml bd posiflush¿ syringe was incorrectly filled to the 3ml marking.There was no report of exposure, serious injury or medical intervention.

• 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: 7526263
• MDR Text Key: 108862543
• Report Number: 1911916-2018-00210
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7264801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• 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