MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LL BNS; PISTON SYRINGE

Catalog Number 301031

Device Problem Volume Accuracy Problem (1675)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported that syringes found with black and white dots and are damaged or broken.To aid in the investigation, ten samples and nine photos were received for evaluation by our quality team.The samples came bulk packaged.A visual inspection was performed and damaged syringe barrels, embedded degraded resin and rubmarks were observed.Rubmarks are imperfections and considered acceptable.The 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 defect, it is likely that a jam occurred during the assembly process resulting in the damage to the syringes.As the lot provided is 'unknown,' a device history record review could not be completed.Verification of the assembly equipment was performed.Alignment of rails and conveyors were acceptable.Flow of products was good.Frequency of inspections were increased to mitigate the embedded degraded resin escapes.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.

Event Description

It was reported syringe 20ml ll bns had incorrect scale markings.The following information was provided by the initial reporter: "black dots: 218 pieces damaged/broken: 102 pieces".

• Brand Name: SYRINGE 20ML LL BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12264124
• MDR Text Key: 265014397
• Report Number: 1911916-2021-00777
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2021

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: 301031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 08/02/2021
• 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