MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383328

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Pain (1994)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 that the diabetic patient received the bd saf-t-intima¿ iv catheter safety system.The next day the patient reported pain and edema was identified as erysipelas.No other action or medical intervention was noted.

Manufacturer Narrative

Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.A review of the device history records and the microbiological tests (pyrogens) in the certificate of sterility, all the units (b)(4) meet with acceptance criteria.Testing revealed no irregularities during the manufacture and sterilization of reported lot number 7115948.Without sample or photo we could not confirm or associate the reported defect to manufacturing process.We could not find a definitive root cause, since no sample or photo was returned for evaluation.No capa was opened since this issue could not be confirmed as manufacturing related.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7183111
• MDR Text Key: 96998000
• Report Number: 9610847-2017-00241
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 383328
• Device Lot Number: 7115948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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
• Patient Outcome(s): Other