MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ STRAIGHT YEL 24GA X 19MM; INTRAVASCULAR CATHETER

Catalog Number 383318

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

Patient Problem Necrosis (1971)

Event Date 08/25/2023

Event Type  Injury  

Event Description

It was reported that the bd saf-t-intima¿ straight yel 24ga x 19mm experienced adverse event without identified device.3 of 6 related files.The following information was provided by the initial reporter, translated from french to english: since the beginning of august, we have been experiencing problems with our subcutaneous infusions: necrosis, subcutaneous abscess, inflammatory injection site requiring the infusion to be removed.Our kt insertion protocols have not changed.Here is the batch of kt and reference that we are currently using: bd saf-t intima 24g reference 383318 lot number 2320424 exp 30-11-2026.Since the beginning, we have had 6 patients affected, including : 2 subcutaneous abscesses, 1 point of necrosis at the injection site, 3 inflammatory injection sites requiring removal of the kt.We obviously have a lot of infused patients at the moment, which mechanically increases the probability of infections on the kt.However, this is the first year that we have had infections on the kt, whereas every summer our proportion of infused patients is the same.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Since the beginning of august, we have been experiencing problems with our subcutaneous infusions: necrosis, subcutaneous abscess, inflammatory injection site requiring the infusion to be removed.Our kt insertion protocols have not changed.Here is the batch of kt and reference that we are currently using: bd saf-t intima 24g reference 383318 lot number 2320424 exp 30-11-2026 since the beginning, we have had 6 patients affected, including : 2 subcutaneous abscesses.1 point of necrosis at the injection site.3 inflammatory injection sites requiring removal of the kt.We obviously have a lot of infused patients at the moment, which mechanically increases the probability of infections on the kt.However, this is the first year that we have had infections on the kt, whereas every summer our proportion of infused patients is the same.

Manufacturer Narrative

1.Dhr review: the complaint lot#2320424, complete the assembly in suzhou plant1 on 2022.Dec.16, lot quantity is (b)(4)ea review the in process test record and outgoing test report, all test results meet the product specifications, no abnormal found.Review the product assembly record, no non-conformities, deviations or rework activities for this lot 2.Sterilize rvw exempt rationale: check the production batch record, the sterilization process is normal, the bi sterility test passed, and the eo residue test passed, the product met the requirement of bi sterility test before released, refer to the attachment coc_383318_2320424 3.Returned sample analysis not able to confirm the indicated failure mode since no returned defective unit sample or photos 4.Causes analysis according to preview ma feedback, there are many factors that cause the skin redness and wellness.Common is mainly caused by drug infusion (including configuration solution).Other possible related factors include: puncture through the blood vessels was not found in time, resulting in leakage or small hematoma caused by local swelling disinfection during operation is not strict and causes infection some drugs may cause skin redness and wellness the physical reasons of the patient itself conclusion: no found any abnormal for the assembly & sterilization process and production line & the production environment.Not able to confirm the indicated failure mode since was not received defective unit sample or photos, so cannot identify the root cause related with production.

• Brand Name: BD SAF-T-INTIMA¿ STRAIGHT YEL 24GA X 19MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17720190
• MDR Text Key: 323081794
• Report Number: 3014704491-2023-00535
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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 Catalogue Number: 383318
• Device Lot Number: 2320424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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): Required Intervention