MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK TIP PISTON SYRINGE

Model Number 302830

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

Patient Problem No Code Available (3191)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. 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 an unspecified number of bd 20ml syringe luer-lok¿ tips experienced difficult plunger movement during use. The following information was provided by the initial reporter: material no. 302830 batch no. Unknown. We have been asked for device and/or drug delivery ideas, by nursing staff experiencing upper extremity strain due to prolonged manual delivery of viscous chemo meds via syringe, iv push or subcutaneous, taking 5 ¿ 45 minutes at a time. (they are reaching out to other jurisdictions, looking at body mechanics, etc, in addition to these enquiries. ).

• Brand Name: BD 20ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• 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 ; 8015652341
• MDR Report Key: 10659898
• MDR Text Key: 212768872
• Report Number: 1911916-2020-00953
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/10/2020 Patient Sequence Number: 1