MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE STERILE; IRRIGATING SYRINGE

Model Number 309620

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd¿ catheter tip syringe sterile the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: it was reported syringe is very difficult to inject back in.

Manufacturer Narrative

H6: investigation summary it was reported the syringe was difficult to inject.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a packaging blister and no other details are available.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 309653, lot number 1356536.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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 could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.

Event Description

It was reported while using bd¿ catheter tip syringe sterile the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: it was reported syringe is very difficult to inject back in.

• Brand Name: BD¿ CATHETER TIP SYRINGE STERILE
• Type of Device: IRRIGATING 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 ; 8015296192
• MDR Report Key: 13659979
• MDR Text Key: 286774102
• Report Number: 1911916-2022-00125
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• 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
• Patient Sequence Number: 1