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

Catalog Number 309658

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 01/10/2019

Event Type  Injury  

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 during use of a bd plastipak¿ syringe luer-lok¿ there was a crack on the body of a 3ml syringe and leakage was observed.A decision was made to delay treatment.

Manufacturer Narrative

Investigation summary: two photos of the same loose 3ml syringe with approximately 0.5ml of clear fluid were received and evaluated.Both photos show a crack extending lengthwise from the 0ml mark to the 1.1ml mark with the location inside the grad lines.Potential root cause for the cracked barrel defect is associated with the assembly or material handling process.No corrective actions are necessary based on the defective rate identified.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.

Event Description

It was reported that during use of a bd plastipak¿ syringe luer-lok¿ there was a crack on the body of a 3ml syringe and leakage was observed.A decision was made to delay treatment.

• Brand Name: BD PLASTIPAK SYRINGE LUER-LOK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8324315
• MDR Text Key: 135677473
• Report Number: 1213809-2019-00162
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096580
• UDI-Public: 30382903096580
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Catalogue Number: 309658
• Device Lot Number: 8140554
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention