MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LS S/C 56 PISTON SYRINGE

Model Number 302833

Device Problem Volume Accuracy Problem (1675)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: illegible scale markings reported. To aid in the investigation, three photos were provided for evaluation by our quality team. A photo shows two packaging blisters with what appears to be residues of ink in the sealing area of the top-bottom web of the packaging blisters. One has what appears to be residues of ink in the sealing area of the top-bottom packaging blister. No other defects or imperfections are observed. A device history record review was completed for provided material number 302833, lot number 9029908. 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 packaging process was performed, including printing and sealing. No conditions were found that could induce the symptoms and the flow of products was good. To date, there have been no other similar events reported for these lots. Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed. We will continue monitoring the complaint trend for this product and symptom. With no sample analysis a probable root cause could not be offered.

Event Description

It was reported that the syringe 30ml ls s/c 56 experienced illegible scale markings. The following information was provided by the initial reporter: lot no. 9029908: 1 tube has illegible markings on the scale.

• Brand Name: SYRINGE 30ML LS S/C 56
• 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: 12422300
• MDR Text Key: 270631673
• Report Number: 1911916-2021-00930
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 302833
• Device Catalogue Number: 302833
• Device Lot Number: 9029908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial