MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte bl 22ga x 1.0in defective needles in cannula.We have some 22g bd insyte cannulas (ref 381223) here that have been reported defective by the anaesthetists using them, all from the same batch (no.4101724).The needle catches on the inside of the cannula if you attempt to reinsert it and some have visible kinks on the outside of the cannula.We have removed this batch from our stock and put aside to prevent further issues.The cannula needle appeared to have a couple very small bumps on the outside.The others he said didn¿t glide smoothly and would catch internally; i believe he had issues with 3 today.His concern was pushing through the plastic and leaving a piece of plastic in the patient.The customer has put aside the remaining stock in a bag and will return all of the leftover stock.I don't have an exact number.None of the used cannulas were kept.
Event or Problem Description
We have some 22g bd insyte cannulas (ref (b)(4) here that have been reported defective by the anaesthetists using them, all from the same batch (no.4101724).The needle catches on the inside of the cannula if you attempt to reinsert it and some have visible kinks on the outside of the cannula.We have removed this batch from our stock and put aside to prevent further issues.The cannula needle appeared to have a couple very small bumps on the outside.The others he said didn¿t glide smoothly and would catch internally, i believe he had issues with 3 today.His concern was pushing through the plastic and leaving a piece of plastic in the patient.The customer has put aside the remaining stock in a bag and will return all of the leftover stock.I don't have an exact number.None of the used cannulas were kept.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned sample, observed a ¿v-cut¿ on the catheter that matches the shape of the bevel, which could be caused by needle pierced through catheter.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needle pierced through catheter could happen during product application when the product was manipulated, or during needle cover removal.Current control, there is outgoing inspection and in-process inspection in place to check for needle pierced through catheter.

• Brand Name: BD INSYTE BL 22GA X 1.0IN
• 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; colosio no. 579; singapore ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20476565
• Report Number: 2243072-2024-01050
• Device Sequence Number: 7471883
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233(11)240411(17)290331(10)4101724
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 381223
• Device Lot Number: 4101724
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown