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

Catalog Number 306547

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).(b)(4).Investigation summary: a device history record review was completed for provided material number 306547 and lot number 0213413.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, six samples were received for evaluation by our quality team.Five samples came in sealed packaging blisters and one sample came in a biohazard plastic bag.The used sample has 2ml of solution and the rubber stopper is at the 5.5ml mark.A visual inspection was performed and no defects or imperfections were observed.Each sample was then test of leakage.No leakage past the stopper was seen.Investigation conclusion: 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.Root cause description: based on the investigation results, the samples received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.Rationale: further action has not been determined necessary at this time.Capa not required at this time.

Event Description

It was reported that syr 10ml pump compatible saline 10ml fil leaked.The following information was provided by the initial reporter: material no: 306547, batch no: 0213143.It was reported the black plunger failed and blood shot out of the rear of the syringe onto the nurse.Verbatim: "hi, they were flushing a central line and when they aspirated then went to push back the black plunger failed and blood shot out of the rear of the syringe onto the nurse.According to the report they have had similar instances with the lot in question.I have one of the failed flushes as well as some from that same lot.".

Manufacturer Narrative

The following fields have been updated with additional information: d.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

Event Description

It was reported that syr 10ml pump compatible saline 10ml fil leaked.The following information was provided by the initial reporter: material no: 306547 batch no: 0213143.It was reported the black plunger failed and blood shot out of the rear of the syringe onto the nurse.Verbatim: hi **** they were flushing a central line and when they aspirated then went to push back the black plunger failed and blood shot out of the rear of the syringe onto the nurse.According to the report they have had similar instances with the lot in question.I have one of the failed flushes as well as some from that same lot.

• 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
• MDR Report Key: 11319316
• MDR Text Key: 232878311
• Report Number: 1911916-2021-00113
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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: 06/30/2023
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1