MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM; PISTON SYRINGE

Catalog Number 320440

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows : lot # : 1004344: device expiration date : 01/31/2026, device manufacture date : 01/04/2021.Lot # : unknown: device expiration date : unknown, device manufacture date : unknown.Initial reporter state: unknown, reported through (b)(6).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 4 bd syringe 0.3ml 31ga 8mm had product damage issues.The following information was provided by the initial reporter : ¿ it was reported by the health professional that the syringe shaft was breaking off upon removal of the cap, needles were dull and no plunger present in the syringe.

Event Description

It was reported that 4 bd syringe 0.3ml 31ga 8mm had product damage issues.The following information was provided by the initial reporter:   it was reported by the health professional that the syringe shaft was breaking off upon removal of the cap, needles were dull and no plunger present in the syringe.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-23.H6: investigation summary: customer returned five 0.3ml syringes with no pouch for identification.The syringes were returned fully intact.A needle shield pull force test was performed on each of these syringes.Removing the needle shields found that the hubs were properly attached to the barrels of the syringes.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.With the needle hubs attached and the needle shields being within pull force specification, the report of the hubs separating from the barrels could not be confirmed for these samples.The outer diameters of these needles were measured.All of the needles were measured within acceptable outer diameters for 31 gauge needles.Flour was applied to the needles¿ cannulas to ensure that lubricant was present.Sufficient lubricant was found on all samples.No damage to the needles of any kind was observed.The needles were within specifications and did not feature any dullness or burrs.Lastly, all of the syringes were observed to have their plunger rods present and intact.However, it was observed that 3 of the 5 syringes featured significant portions of their surface markings missing.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of missing plunger rods, dull needles, and failure of hub separation.H3 other text : see h10.

• Brand Name: SYRINGE 0.3ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12284534
• MDR Text Key: 265372146
• Report Number: 1920898-2021-00855
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320440
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1