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

Catalog Number 306574

Device Problem Nonstandard Device (1420)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: two (2) samples were received for evaluation by one of our quality engineers.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 3ml mark; this is 5ml syringe therefore failure mode is verified.Possible root cause is an escape when the low fill volume was detected in the process inspections.It is possible that the product with low fill volume may have made it through to packaging.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history review was completed and there is documentation for low fill volume being found twice during plunger rod quality control checks on october 8, 2017.An acceptable quality limit of 0.25% was performed each time and both checks passed.Investigation conclusion: 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 jun 05, 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 3ml mark; this is 5ml syringe.Product within specification? yes/no.Root cause description: possible root cause could be product with low fill volume may have made it through to packaging.Update jun 05, 2018.Possible root cause.An escape when the low fill volume was detected in the process inspections.Rationale: capa not required for this event.

Event Description

It was reported that the bd posiflush¿ sp saline flush syringe had less than normal saline.The amount was 3ml rather than the normal 5ml.Found before use.No reports of serious injury or medical intervention noted.

• Brand Name: BD POSIFLUSH¿ SP 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: 7611880
• MDR Text Key: 111854408
• Report Number: 1911916-2018-00299
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• 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: 06/04/2018

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: 08/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7264801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/18/2018
• 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