MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE VASCULAR ACCESS FLUSH

Model Number 306547

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed for provided material number (b)(4) and lot number (b)(4).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, one physical sample was received for evaluation by our quality team.The sample came with no packaging flow wrap or tip cap and the plunger rod-rubber stopper at the 2ml mark.A visual inspection was performed and no damage or imperfections were observed.The sample was then tested for sustaining force and all results, though on the higher end, were found to be within specification.Investigation conclusion: based on the investigation with the sample analysis the symptom reported by the customer could not be confirmed.Root cause description: it could be possible that the customer noticed that additional force than normal was needed.Rationale: 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 the syr 10ml pump compatible saline 10ml fil plunger was stuck and could not be pushed in.The following information was provided by the initial reporter: "when the syringer was been used to flush a line, the plunger got stuck and could not be pushed down.A good 7ml, was pushed out but the plunger was stuck, another flush was used and no issues experienced.No pt involvement, incident occurred before patient use".

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11312225
• MDR Text Key: 232346332
• Report Number: 1911916-2021-00109
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 0281381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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