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

Catalog Number 309658

Device Problems Product Quality Problem (1506); Device Damaged Prior to Use (2284); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Investigation summary: a single loose 3ml syringe was received, reported to be from batch # 7001975 (p/n 309658).The sample was visually evaluated.The syringe was found to have flash circle around the bottom edge of the stopper.The flash at the stopper made the stopper look deformed and damaged.Product defect could be confirmed based on sample evaluation.Furthermore, 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.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: dhr review for batch 7001975 (p/n 309658): manufacturing dates: 01/15/2017 to 01/18/2017.Batch quantity was 768,000.Assembly record was reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7001975 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Root cause description: root cause and capa not required based on severity and occurrence level defined for this complaint.

Event Description

It was reported that before use a bd plastipak¿syringe luer-lok ¿ malfunctioned as "the plunger (it¿s the plunger stopper ¿ the black part) has started to disintegrate." there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD PLASTIPAK ¿ SYRINGE LUER-LOK¿
• Type of Device: HYPODERMIC 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: 7571495
• MDR Text Key: 110362937
• Report Number: 1213809-2018-00348
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096580
• UDI-Public: 30382903096580
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K980987
• 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
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 309658
• Device Lot Number: 7001975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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