MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381244
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte gn 18ga x 1.16in catheter broke / separated after placement.It was reported by customer that upon removing catheter from xxxxx, about 2/3rds of the catheter was missing.Ran radiographs and to find if it was there, sent to radiologist but could not see anything, additional testing but could not confirm it was left in side the pt.Verbatim: rcc received a complaint via phone.Pir attached.Veterinary: xxx contact: xxxx address: xxxx phone: xxx email: xxx ref: 381244 lot: 3328426 issue: upon removing catheter from xxxxxx, about 2/3rds of the catheter was missing.Ran radiographs and to find if it was there, sent to radiologist but could not see anything, additional testing but could not confirm it was left in side the pt.Sample: yes requesting sample return kit pt harm: no.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 381244, batch # 3328426.It was reported by customer that upon removing catheter from xxxxx, about 2/3rds of the catheter was missing.Ran radiographs and to find if it was there, sent to radiologist but could not see anything, additional testing but could not confirm it was left inside the pt.Verbatim: rcc received a complaint via phone.Pir.Veterinary: xxx, contact: xxxx, address: xxxx, phone: xxx, email: xxx, ref: (b)(4), lot: 3328426.Issue: upon removing catheter from xxxxxx, about 2/3rds of the catheter was missing.Ran radiographs and to find if it was there, sent to radiologist but could not see anything, additional testing but could not confirm it was left inside the pt.Sample: yes.Requesting sample return kit pt harm: no.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is an in-process visual inspection to detect catheter tubing damage.There is also outgoing functional test in place to check for catheter to adapter pull force.As no sample is returned for evaluation, actual root cause could not be established.
Additional Manufacturer Narrative
The reported issue of catheter broke/ separated after placement was confirmed upon inspection of the samples.Analysis of the samples showed the catheter broken and signs of blood in/ on the broken portion of the catheter.The broken portion of the catheter was observed with a smooth edge which indicated a clean cut on the catheter.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this lot meets our manufacturing specification requirements.A simulation was carried out by using scissors to cut on the tubing.It was observed that the cut off portion area has a similar smooth edge as the complaint sample.Therefore, the broken catheter was concluded to be cut by an unknown sharp object and the defect happened outside of the manufacturing facility.According to the instructions for use, it indicates that scissors or other sharp instruments should be used at or near the insertion site.It is therefore recommended to follow the instructions accordingly.
Event or Problem Description
Material # 381244.Batch # 3328426.It was reported by customer that upon removing catheter from xxxxx, about 2/3rds of the catheter was missing.Ran radiographs and to find if it was there, sent to radiologist but could not see anything, additional testing but could not confirm it was left in side the pt.Verbatim: rcc received a complaint via phone.Veterinary: xxx.Contact: xxxx.Address: xxxx.Phone: xxx.Email: xxx.Ref: 381244.Lot: 3328426.Issue: upon removing catheter from xxxxxx, about 2/3rds of the catheter was missing.Ran radiographs and to find if it was there, sent to radiologist but could not see anything, additional testing but could not confirm it was left in side the pt.Sample: yes requesting sample return kit.Pt harm: no.

• Brand Name: BD INSYTE GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20452947
• Report Number: 2243072-2024-01038
• Device Sequence Number: 12540160
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: (01)00382903812448(11)231203(17)281130(10)3328426
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381244
• Device Lot Number: 3328426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 11/05/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/21/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Sex: Unknown
• Patient Weight: 34 KG