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

Catalog Number 301073

Device Problems Break (1069); Volume Accuracy Problem (1675)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1176912.Medical device expiration date: 2026-05-31.Device manufacture date: 2021-06-25.Medical device lot #: 1300340.Medical device expiration date: 2026-09-30.Device manufacture date: 2021-10-27.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 1 bd luer-lok¿ syringe had illegible scale printing, and 2 syringes had broken barrels/flanges.The following information was provided by the initial reporter, translated from (b)(6): "1 syringe bad printing, 2 syringes broken parts".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1176912.Medical device expiration date: 2026-05-31.Device manufacture date: 2021-06-25.Medical device lot #: 1300340.Medical device expiration date: 2026-09-30.Device manufacture date: 2021-10-27.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 1 bd luer-lok¿ syringe had illegible scale printing, and 2 syringes had broken barrels/flanges.The following information was provided by the initial reporter, translated from (b)(6): "1 syringe bad printing, 2 syringes broken parts".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-03-01.H6: investigation summary: five loose 3ml syringes (p/n 301073) were received.The samples were visually evaluated.Two samples were missing the rubber stopper.One sample was observed to have a skewed scale marking, missing scale print and barrel damage just below the flange.One sample was severely damaged and not fit for use.The last sample was observed to have scuff damage on the print scale near the zero-line, faint print markings opposite the printed scale and barrel damage.All the observed conditions were non-conforming per product specification.Potential root cause for the scale marking defects are associated with the marking process.It is likely improper feed resulting in damage as the part entered the printhead led to the skewed scale condition.Potential root cause for the missing stopper and severe damage defects are associated with the assembly process.A new procedure for adjusting the infeed into the printhead was implemented to help mitigate the skewed scale defect for 3ml products.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batches 1176912 and 1300340 are considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided possible batches 1176912 and 1300340 that could have contributed to the reported defect.H3 other text : see h10.

Event Description

It was reported that 1 bd luer-lok¿ syringe had illegible scale printing, and 2 syringes had broken barrels/flanges.The following information was provided by the initial reporter, translated from dutch: "1 syringe bad printing, 2 syringes broken parts".

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13551168
• MDR Text Key: 286020636
• Report Number: 1213809-2022-00083
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301073
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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