MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE .5ML 30GA TW 8MM BLS; PISTON SYRINGE

Catalog Number 305934

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that the bd syringe.5ml 30ga tw 8mm bls was missing the scale markings.The following information was provided by the initial reporter, translated from (b)(6) to english: scale missing.

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd syringe.5ml 30ga tw 8mm bls was missing the scale markings.The following information was provided by the initial reporter, translated from chinese to english: scale missing.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 11/23/2021 h.6.Investigation: customer returned (1) loose bd safetyglide insulin syringe without any packaging.Customer states that the scale is missing.The returned syringe was examined and exhibited no scale markings printed on the barrel.Unable to perform dhr check for scale marking missing due to unknown lot number.Root cause for this defect cannot be determined.Dhr, l2l dispatches, and logbook entries could not be looked at as no lot number was given.H3 other text : see h.10.

• Brand Name: BD SYRINGE .5ML 30GA TW 8MM BLS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12861662
• MDR Text Key: 281149521
• Report Number: 1920898-2021-01233
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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