MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEN NEEDLE 31GX5MM

Catalog Number 329490

Device Problem Failure to Deliver (2338)

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

Event Date 12/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: 1.Lot#: 9093614dhr was reviewed and no qn found.2.Manufacture records were reviewed, no abnormality was found.3.Pen needle product has 100% clog test in flowguru station, and defect part will be rejected by flowguru station automatically.4.Clog test was conducted on 14pcs retention samples and all no needle clog found.5.3rd attempt were made for defect sample requested yet not received from customer by customer care.No returned samples or actual defect samples for investigation, so we can¿t performing in-depth investigation.6.Base on investigation, the certain cause cannot be concluded at the moment.Investigation conclusion: based on the investigation above, the certain cause cannot be concluded at the moment.However, we will keep monitor on similar issue from filed and trending regularly.Rationale: according to dfema 149rmn-0004-03, the severity of cannula clog is moderate(s3), the actual complaint rate of pen needle clog is less than 1 cpm(o1) since from 2017.According to cpr-028, the risk level is low, no need to open capa.

Event Description

It was reported that 4 pen needle 31gx5mm were unable or difficult to prime, and unable to deliver insulin/medication during use.The following information was provided by the initial reporter: 2 pen needles were noticed that cannula clog during usage.2 pen needles were noticed that cannula clog during priming.

• Brand Name: PEN NEEDLE 31GX5MM
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9512361
• MDR Text Key: 180721062
• Report Number: 3006948883-2019-01122
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 329490
• Device Lot Number: 9093614
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• 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
• Patient Outcome(s): Other