MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

Catalog Number 309658

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 08/21/2017

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.Udi: (b)(4).

Event Description

It was reported that the plunger top of the bd plastipak¿ 3ml syringe luer-lok¿ was broken creating discomfort when attempting to inject.No reported medical intervention or serious injury.

Manufacturer Narrative

On 9/5/2017, i received 1 sample from bd (b)(4), which will be sent to canaan for investigation on 9/8/2017.Dhr review for batch 7060629 (p/n309658): manufacturing dates: 03/22/2017 - 03/23/2017.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7060629 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: one opened 3ml packaged syringe was received by bd canaan and confirmed to be from batch #7060629 (p/n 309658).The sample was visually evaluated.The syringe plunger rod is missing the thumb rest.It appears the thumb rest broke off the plunger rod.Based on the sample evaluation: confirmed: bd canaan was able to confirm the customer's indicated failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.

• Brand Name: BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6865549
• MDR Text Key: 86632835
• Report Number: 1213809-2017-00110
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 309658
• Device Lot Number: 7060629
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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
• Patient Outcome(s): Other