MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Volume Accuracy Problem (1675)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a device history record review was completed for provided material number 306546 and lot number 0261394.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, seven physical samples and three photos were provided for evaluation by our quality team.The samples came in sealed packaging flow wraps.All the samples have no syringe barrel label and no other defects or imperfections were observed.Two of the three photos provided show the samples received.The other photo shows a shelf box label.It could be possible for this defect to occur during the stop-start of the labeler process inducing the barrels missing the labels not detected in the next processes.Based on the investigation with the returned sample and photo sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.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.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause.During the stop-start of the labeler parts with missing label may go through and not detected in the next processes.

Event Description

It was reported that 7 syringe 10ml reg pr saline 10ml fill experienced missing scale marking.The following information was provided by the initial reporter: material no.:306546 batch no.:0261394 several syringes are blank with no markings ( no volumetric markings, expiration, or lot numbers).Label for volumetric markings missing from seven (7) saline flush syringes.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• 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: 11520284
• MDR Text Key: 242274495
• Report Number: 1911916-2021-00224
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 306546
• Device Lot Number: 0261394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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