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 Problem Leak/Splash (1354)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syr 10ml pump compatible saline 10ml fil experienced the tip/luer of syringe broken off which was noted during use.The following information was provided by the initial reporter: material no: 306547 batch no: 9351580.It was reported by the customer that the iv tubing set cracked and broke off after the rn flushed and disconnected the syringe.During visual inspection, it was observed that the male luer tip from the 10ml bd syringe was broken off and lodged inside the female luer of the reported suspect extension set.No issues were observed on the female luer of the extension set.

Manufacturer Narrative

H.6.Investigation summary: it was reported the item was broken.A device history review was conducted for lot number 9351580.There was no documentation for this type of defect during the entire production run of this batch.Three photos were provided.One photo shows a syringe with the barrel label, another photo shows the syringe luer tip in the iv extension set.The third photo shows the syringe luer with the tip missing.The posiflush platform was contacted.After an investigation with the dchu it was confirmed that an onsite investigation was performed.Findings from the site visit determined that there is most likely a correlation to the usage of alcohol products (in the form of tips) and the incidences of cracked, broken or crumbled fixed collars on make luer end of set me2017.If proper dry times are not followed after scrubbing the hub, alcohol binding may result causing the reported failure modes.With the continued use of alcohol products; bd has proposed alternate products that will have improved product performance.The improved chemical resistance, including alcohol resistance, is due to the materials used in manufacturing the male and female luers.Root cause: can¿t be confirmed.Nothing in the bd manufacturing process has been identified that could contribute to this failure mode.H3 other text : see h.10.

Event Description

It was reported that the syr 10ml pump compatible saline 10ml fil experienced the tip/luer of syringe broken off which was noted during use.The following information was provided by the initial reporter: material no: 306547, batch no: 9351580.It was reported by the customer that the iv tubing set cracked and broke off after the rn flushed and disconnected the syringe.During visual inspection, it was observed that the male luer tip from the 10ml bd syringe was broken off and lodged inside the female luer of the reported suspect extension set.No issues were observed on the female luer of the extension set.

• 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: 10016090
• MDR Text Key: 189912796
• Report Number: 1911916-2020-00425
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 9351580
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other