MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309657

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

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

Event Date 03/07/2019

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 a 3 ml bd luer-lok¿ luer-lok¿ tip had sterile breach.The following was reported, "material no.309657; batch no.8241646.It was reported the packing on two syringes were not sealed properly."description of issue: contact states that packing on two syringes were not sealed properly.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Number of occurrences: 2.Item number: 3 ml syringe ¿ 309657.Product lot number: 8241646.Are samples available for investigation? yes.Does customer authorize bd to contact customer to obtain sample(s)? yes.Did issue cause any injury? if yes, what type of injury? contact states no injuries.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? contact states no resulting injuries.Resolution cts explained that bd might follow up with customer regarding returning syringe/needle.No further tandem follow up is required.".

Manufacturer Narrative

Investigation: during the dhr a quality notification for open seal defect was issued during the manufacture of this batch.Adjustments were made and product was requalified per applicable aql before production resumed.Since no samples displaying the reported condition were received no defects could be confirmed.Potential root cause for the open seal defect is associated with the packaging process.Corrections took place during the time the defect was found in production.

Event Description

It was reported that a 3 ml bd luer-lok¿ luer-lok¿ tip had sterile breach.The following was reported."material no.309657 batch no.8241646.It was reported the packing on two syringes were not sealed properly."description of issue: contact states that packing on two syringes were not sealed properly.2.Did the customer insert the needle into the cartridge and encounter fill resistance? o no.3.Number of occurrences: 2 4.Item number , 3 ml syringe 309657, 5.Product lot number: 8241646, 6.Are samples available for investigation? o yes.Does customer authorize bd to contact customer to obtain sample(s)? yes.7.Did issue cause any injury? if yes, what type of injury? contact states no injuries.8.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? contact states no resulting injuries.9.Resolution.Cts explained that bd might follow up with customer regarding returning syringe/needle.No further tandem follow up is required.".

• Brand Name: 3 ML BD LUER-LOK LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8471562
• MDR Text Key: 146544742
• Report Number: 1213809-2019-00400
• Device Sequence Number: 0
• Product Code: FMF
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 309657
• Device Lot Number: 8241646
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 MO