MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE COMBINATION; SYRINGE AND NEEDLE

Catalog Number 309571

Device Problems Break (1069); Detachment Of Device Component (1104); Material Separation (1562)

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

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

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 the needle of the bd luer-lok¿ syringe with precisionglide¿ needle combination separated during use and broke off when she was administering her husbands monthly dosage.No reported injury or medical intervention noted to her husband.Found during use.

Manufacturer Narrative

Correction: this complaint (b)(4).Is a duplicate of complaint (b)(4).See mdr # 1213809-2018-00422.

Event Description

It was reported that the needle of the bd luer-lok¿ syringe with precisionglide¿ needle combination "separated" during use and broke off when she was administering her husbands monthly dosage.No reported injury or medical intervention noted to her husband.Found during use.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE COMBINATION
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7647225
• MDR Text Key: 112852855
• Report Number: 1213809-2018-00388
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903095711
• UDI-Public: 00382903095711
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 309571
• Device Lot Number: 7093988
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other