MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 30654778

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: the date of event was provided as 2020-01-11 for one of the three occurrences, but the date of event for the other is unknown (b)(4).Investigation summary: a device history record review was completed for provided material number 30654778 and lot number 0218163.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, five physical samples were received for evaluation by our quality team.The samples came with no packaging flow wrap and no tip cap.A visual inspection was performed and no defects or imperfections were observed.Each sample was then tested for sustaining force and all results were within specification.Based on the investigation results, the sample received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 3 10 ml bd posiflush" normal saline syringes experienced difficult plunger movement.The following information was provided by the initial reporter: material no.: 306547, batch no.: 0218163.It was reported that the syringe would stop/lock up midway through the flush.We have seen an uptick in issues the last week and we originally thought it was the needless connector but now know its the flush.I have like 4 syringes kept for me (originally because i wanted to see what was occurring) luckily no harm to patients or issue with ivs, we just thought the iv that was good suddenly stopped working and realized it was the flush.They flush until the 6ml point and then they lock up and dont flush.Its really weird.Its really hard to flush- like it gets hung up on something? i have about 4 here, but no patient info.Just the syringes with 2-4ml left in them from us trying to force them to flush.

• Brand Name: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS 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 ; 8015296192
• MDR Report Key: 11276037
• MDR Text Key: 231368183
• Report Number: 1911916-2021-00088
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 30654778
• Device Lot Number: 0218163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• 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