MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE

Catalog Number 309628

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(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 rubber plunger of the bd luer-lok¿ disposable syringe, detaches from the white plunger rod. Staff reports being able to sometimes push the plunger back in to start over. Found during use. No reports of serious injury or medical intervention noted.

Event Description

It was reported that rubber plunger of the bd luer-lok¿ disposable syringe, detaches from the white plunger rod. Staff reports being able to sometimes push the plunger back in to start over. Found during use. No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: one 1ml ll syringe inside an opened package was received taped to piece of paper. The sample was confirmed to be from batch #7235566 (p/n 309628). It was evaluated. No visual defects were observed. The plunger had the stopper attached and was at the bottom out position. The plunger was pulled back until the break out occurred ¿ the stopper remained attached to the plunger rod. The plunger was exercised to the 1ml marking and back down to zero. No defects were found in the sample received. No root cause or corrective actions can be determined as no defects were confirmed. Also, this is the 1st related complaint for stopper seperation from plunger on the provided lot number 7235566. Moreoever, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect. Investigation conclusion: the reported defect was not identified in the samples received. Unable to determine a root cause.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted field: device returned to manufacture: yes.

Event Description

It was reported that rubber plunger of the bd luer-lok disposable syringe, detaches from the white plunger rod. Staff reports being able to sometimes push the plunger back in to start over. Found during use. No reports of serious injury or medical intervention noted.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7634523
• MDR Text Key: 112437659
• Report Number: 1213809-2018-00369
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: 00382903096282
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 309628
• Device Lot Number: 7235566
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/25/2018 Patient Sequence Number: 1