MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP); CATHETER

Catalog Number 383328

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erythema (1840); Inflammation (1932)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Additional device lot #: 9057767; additional device expiration date: 2023-02-28.Additional device manufacture date: 2019-03-15.

Event Description

It was reported that bd saf-t-intima¿ safety system with removable prn 22 ga 0.75 in (non-dehp) led to irritation/inflammation.The following information was provided by the initial reporter: "over a period of 5-6 weeks, 3 patients developed severe inflammation at the puncture site (inflammation, induration, redness).One patient even had an abscess that had to be evacuated quickly.These catheters have been used for several years, the antisepsis protocol seems to have been respected, as well as the duration of insertion.Actions taken: alcohol-based dressing for the 3 patients to reduce inflammation.Devices not kept.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot numbers 9119696 and 9057767.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality inspections were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Upon assembly, the product is sent for sterilization.The microbiological test results and the certificate of sterilization were reviewed for the provided lot numbers; no abnormalities were found.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.

Event Description

It was reported that bd saf-t-intima¿ safety system with removable prn 22 ga 0.75 in (non-dehp) led to irritation/inflammation the following information was provided by the initial reporter: "over a period of 5-6 weeks, 3 patients developed severe inflammation at the puncture site (inflammation, induration, redness).One patient even had an abscess that had to be evacuated quickly.These catheters have been used for several years, the antisepsis protocol seems to have been respected, as well as the duration of insertion.Actions taken: alcohol-based dressing for the 3 patients to reduce inflammation.Devices not kept.".

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP)
• Type of Device: CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9908067
• MDR Text Key: 190979278
• Report Number: 9610847-2020-00117
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 383328
• Device Lot Number: 9119696
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other