MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 30ML LL BNS; PISTON SYRINGE

Catalog Number 301033

Device Problems Break (1069); Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

It was reported that 151 bd syringe 30ml ll bns contained foreign matter, 84 were damaged, but still operable, 15 had scale marking issues, and 1 had a broken plunger rod.The following information was provided by the initial reporter: "it was reported that there were black dots, bad impression, and damaged/broken pieces.".

Manufacturer Narrative

It was reported there were black dots, bad impressions and damaged or broken pieces.To aid in the investigation, ten bulk packaged samples and four photos were received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.Six samples are damaged, three samples have embedded degraded resin and one sample has an defect with the scale printing.No other defects or imperfections were observed.The four photos provided show the samples received.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.For the damaged parts and printing issue defects, it is likely that a jam occurred during the assembly process resulting in the damage to the syringes.A device history record review was completed for provided material number (b)(4), lot number 1005399.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the assembly process was performed.The settings were correct and the flow of products was good.To mitigate the risk of embedded degraded resin escapes, the frequency of inspections were increased.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.It was reported there were black dots, bad impressions and damaged, or broken pieces.To aid in the investigation, ten samples and four photos were received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.Seven samples have embedded degraded resin, one sample has barrel damage, one sample has a barrel printing issue and one sample was found with no defects or imperfections observed.The four photos provided show some of the samples received.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.For the damaged parts and printing issue defects, it is likely that a jam occurred during the assembly process resulting in the damage to the syringes.A device history record review was completed for provided material number (b)(4), lot number 1056881.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Verification of the assembly process was performed.The settings were correct and the flow of products was good.To mitigate the risk of embedded degraded resin escapes, the frequency of inspections were increased.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 30ML LL BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12724646
• MDR Text Key: 280472391
• Report Number: 1911916-2021-01123
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301033
• Device Lot Number: 1005399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1