MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Model Number 383313

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 while using bd saf-t-intima¿ safety system with y adapter 24 ga 0.75 in a loose needle was discovered.The following information was provided by the initial reporter: the catheter came with the needle bent and loose (rotating).Was the reported incident noticed before, during, or after use on the patient? before.Was there any harm to the patient/healthcare provider? (detail) no.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 while using bd saf-t-intima¿ safety system with y adapter 24 ga 0.75 in a loose needle was discovered.The following information was provided by the initial reporter: the catheter came with the needle bent and loose (rotating).Was the reported incident noticed before, during, or after use on the patient? before.Was there any harm to the patient/healthcare provider? (detail) no.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 24 ga 0.75 in a loose needle was discovered.The following information was provided by the initial reporter: the catheter came with the needle bent and loose (rotating).¿ was the reported incident noticed before, during, or after use on the patient? before.¿ was there any harm to the patient/healthcare provider? (detail) no.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05-may-2022.H.6.Investigation: our quality engineer inspected the 2 photos and 1 used sample submitted for evaluation.The reported issue was confirmed upon inspection of the photos and sample.The needle of the sample is severely bent at the end of the catheter wings.Bd cannot confirm the cause of the failure to our manufacturing process since the observed bend would make it impossible for the product to be placed into the molded packaging.Also, since the sample was returned in a used state, we are unable to determine if the defect occurred during the handling and transportation of the product.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 24 ga 0.75 in a loose needle was discovered.The following information was provided by the initial reporter: the catheter came with the needle bent and loose (rotating).Was the reported incident noticed before, during, or after use on the patient? before.Was there any harm to the patient/healthcare provider? (detail) no.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13295755
• MDR Text Key: 285768489
• Report Number: 9610847-2022-00010
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013800
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 1053927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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