MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA W/PRN BL 22GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number 383322

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/21/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd saf-t-intima w/prn bl 22ga x.75in had foreign matter the following information was provided by the initial reporter; on (b)(6) 2023 the gynecology nurse opened the package of the indwelling needle prior to performing a puncture on a patient and found a foreign body in the catheter, which has occurred several times recently, resulting in the need to re-disconnect the needle and increasing the cost of the unit, and the chief nursing officer has serious suspicions about the quality and safety of the indwelling needle, and would like to find out what the cause of the foreign body is and to provide an answer.

Event Description

No additional information was provided.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photo.Inspection of the photo showed that there was an unknown material attached to the catheter.However, bd cannot confirm the cause of the failures to our manufacturing process since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD SAF-T-INTIMA W/PRN BL 22GA X .75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18107284
• MDR Text Key: 329009008
• Report Number: 9610847-2023-00305
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833222
• UDI-Public: (01)30382903833222
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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: Health Professional
• Device Catalogue Number: 383322
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 11/29/2023
• 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