MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Model Number 302830

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 12 bd luer-lok¿ tip syringes were not sealed correctly in the packaging, compromising their sterility.The following information was provided by the initial reporter: "we have 20 cc syringes in a box where the sterility packages have been compromised.We cannot use these nonsterile syringes." "not sure if you need to report this or not.The 1st syringe in every row isn't sealed correctly thus not sterile.There are 12 in this box.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/23/2021.H.6.Investigation: it was reported that there is a box where the sterility of the packages have been compromised.To aid in the investigation, two shelf boxes, each with forty-eight units, for a total of ninety-six units in packaging blisters were received for evaluation by our quality team.A visual inspection was performed.The packaging blisters are in sets of four and each set has one packaging blister with an open seal.The open packaging blister is at one of the sides in each set.No other defects or imperfections were observed.This defect could be possible during the packaging process if, during the slitting operation, a process variation occurred inducing the packaging web being cut short.A device history record review was completed for provided material number 302830, lot number 1180467.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The packaging process was reviewed.The settings and adjustments were correct.The slitting process was working correctly.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that 12 bd luer-lok¿ tip syringes were not sealed correctly in the packaging, compromising their sterility.The following information was provided by the initial reporter: "we have 20 cc syringes in a box where the sterility packages have been compromised.We cannot use these nonsterile syringes." "not sure if you need to report this or not.The 1st syringe in every row isn't sealed correctly thus not sterile.There are 12 in this box.".

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12520422
• MDR Text Key: 273339636
• Report Number: 1911916-2021-01020
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 1180467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1