MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ ENTERAL SYRINGE; PISTON SYRINGE

Catalog Number 305860

Device Problem Crack (1135)

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

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary - it was reported there was a crack in the plastic of the syringe barrel.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe with no packaging blister and the plunger rod all the way down.There is what appears to be a crack that starts at the bottom of the syringe barrel up to the 4ml of the graduation scale.No other defects or imperfections were observed.A device history record review was completed for provided material number 305860, lot 2210980.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd¿ enteral syringe plastic was cracked.The following information was provided by the initial reporter: crack in plastic of syringe barrel.

Event Description

It was reported that the bd¿ enteral syringe plastic was cracked.The following information was provided by the initial reporter: crack in plastic of syringe barrel.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-may-2023.H6: investigation summary it was reported there was a crack in the plastic of the syringe barrel.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and the syringe barrel has a crack that is about 1" long.The photo shows a syringe with no packaging blister and the plunger rod all the way down.There is what appears to be a crack that starts at the bottom of the syringe barrel up to the 4ml of the graduation scale.No other defects or imperfections were observed.This defect could occur if the sample jammed in one of the conveyors.A device history record review was completed for provided material number 305860, lot 2210980.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

• Brand Name: BD¿ ENTERAL SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16705165
• MDR Text Key: 312954447
• Report Number: 1911916-2023-00221
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305860
• Device Lot Number: 2210980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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