MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGES; PISTON SYRINGE

Model Number 328509

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2269258.D4.Medical device expiration date: 31-oct-2027.H4.Device manufacture date: 26-sep-2022.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using relion insulin syringes foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: spouse called on behalf of spouse.Stated, when he pushed down on plunger rod prior to injection, "liquid" came out.Stated his spouse did not use syringes with "liquid" found inside the barrel.Stated, some needles are dull.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 08may2023.H6: investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.(b)(4) was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported while using relion insulin syringes foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: spouse called on behalf of spouse.Stated, when he pushed down on plunger rod prior to injection, "liquid" came out stated his spouse did not use syringes with "liquid" found inside the barrel stated, some needles are dull.

• Brand Name: RELION INSULIN SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16740469
• MDR Text Key: 313351554
• Report Number: 1920898-2023-00222
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: (01)00681131311762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 328509
• Device Catalogue Number: 328509
• Device Lot Number: 2220112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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