MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number 383323

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

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

Event Date 07/14/2023

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 while using bd saf-t-intima¿ safety system with y adapter 22 ga 0.75 in the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.Verbatim: all for saf-t-intima: no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 2292363.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Due to customs law in china, used or opened medical devices cannot be imported into the country.High resolution photographs of the male and female connection were taken and submitted to the engineering team.No obvious damage could be observed in the returned device, and functional testing of the retention samples for this lot were unable to replicate the reported nonconformance.Based on the available information our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 22 ga 0.75 in the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.Verbatim: all for saf-t-intima: no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.

Manufacturer Narrative

Dhr review: the complaint lot# is 2287487, sku is 383323, assembly in suzhou plant on 2022.Nov.4, lot quantity is (b)(4).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.Returned sample analysis: no returned sample was sent back, there are 3 images attached to show the defect sample which have been used, and cannot get a clear status for needle tip and catheter tip.There is one additional photo attached later, and it shows the needle punctured the side of the catheter sheath, it should be a second time puncture issue, needle tip goes forward and puncture the catheter, normal needle retraction operation will not puncture the catheter, we suggest customer to follow the ifu for operation.Retain sample analysis: sampling 2ea from the retain sample of the same lot to check the needle and catheter assembly status.Both product lie distance and puncture function are normal.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, product lie distance is poor and cause puncture failure, flash back is failure as well.The possible causes are as: as puncture failure, possible causes may be lie distance setting is incorrect during manual assembly, or product lie distance changed during packaging or transportation.As flash back failure, possible causes may be fm in cannula; or stylet/cannula crimping position is poor, or the needle notch is blocked.Manufacture process have take control procedure as below for above possible risks: common inspection is performed to check lie distance in each process station after lie distance is set.100% inspection for the incoming cannula material, purpose to prevent needle clog issue.Both production and quality team sampling check for lie distance and do flash back test there is no sample returned, one image is provided to show 3 samples which have been used, lie distance is incorrect, needle is bent.The image does not show a typical defect feature about the needle tip and the inside of needle, or needle notch status; the additional photo shows the needle punctured the side of the catheter sheath, it should be a second time puncture issue, needle tip goes forward and puncture the catheter.The product is one time puncture design as described in ifu, normal needle retraction operation will not puncture the catheter.With these information the actual defect feature is not clear.The retained sample analysis result is positive, there is no same defect detected with retained sample, so the root cause is not clear.

Event Description

Mat#: 383323; lot#:2287487.It was reported by customer that no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.Verbatim: all for saf-t-intima: no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.Comments received on monday, 07/17/2023 at 7:29 am: "thank you, i am working on gathering the defective items in order to return for qa analysis.Can you provide a shipping label? hi, i am in the office and only have the defective product for the complaints related to the sheath being longer than the needle.Comments received on 17 aug 2023: i am sending all three as they are all from different lots: 2292363; 2294531; 2320486.If i receive the other defective items, i will reach back out.".

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17445866
• MDR Text Key: 320256052
• Report Number: 3014704491-2023-00414
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: (01)30382903833239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923702
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

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: Other
• Device Catalogue Number: 383323
• Device Lot Number: 2287487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/22/2023; 10/30/2023
• Supplement Dates FDA Received: 10/03/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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