MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INSYTE PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381233
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
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 pnk 20ga x 1.0in leaked.It was reported by the consumer reported the issue the customer is having is they are leaking from the pink connector, and this could increase the risk of infection i have attached our product complaint form.We will be crediting the customer 7 boxes.Verbatim: rcc received a complaint via email.Email(s) attached.We have received a complaint for 7 boxes.The issue the customer is having is they are leaking from the pink connector and this could increase the risk of infection i have attached our product complaint form.We will be crediting the customer 7 boxes.Please let me know how to proceed.Occurrences: recurring - customer did not record.Product description: catheter iv insyte 20x1.01in pink.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.All the returned representative samples passed visual inspection and functional tests results were within the product specifications.As current controls, there are outgoing and hourly in-process visual inspections in place to check for adapter and tubing damage.There is also a daily outgoing functional test in place to check for catheter leakage.As the actual sample was not returned for investigation, the actual root cause could not be determined.
Event or Problem Description
Material#: 381233.Lot#: 2234335.It was reported by the consumer reported the issue the customer is having is they are leaking from the pink connector, and this could increase the risk of infection i have attached our product complaint form.We will be crediting the customer 7 boxes.Verbatim: rcc received a complaint via email.Email(s) attached.We have received a complaint for 7 boxes of item 333-381233 lot#2234335 exp.2027-08-31.The issue the customer is having is they are leaking from the pink connector and this could increase the risk of infection i have attached our product complaint form.We will be crediting the customer 7 boxes.Please let me know how to proceed.Occurrences: recurring - customer did not record product code: 381233.Product description: catheter iv insyte 20x1.01in pink lot/serial #: (b)(6).Expiry date: 8/31/2027.
Additional Manufacturer Narrative
Photo evaluation: 1 photo was received for investigation.Unable to evaluate the reported leakage defect from the returned photo due to the photo was only showing a zoom out view of the products inside packaging.Based on device history record review, no abnormality was observed during the production of the affected batches.As current controls, there are outgoing and hourly in-process visual inspections in place to check for adapter and tubing damage.There is also a daily outgoing functional test in place to check for catheter leakage.As the actual sample was not returned for investigation, the actual root cause could not be determined.
Event or Problem Description
Material#: 381233 lot#: 2234335 it was reported by the consumer reported the issue the customer is having is they are leaking from the pink connector, and this could increase the risk of infection i have attached our product complaint form.We will be crediting the customer 7 boxes.Verbatim: rcc received a complaint via email.Email(s) attached.We have received a complaint for 7 boxes of item 333-381233 lot#2234335 exp.2027-08-31.The issue the customer is having is they are leaking from the pink connector and this could increase the risk of infection i have attached our product complaint form.We will be crediting the customer 7 boxes.Please let me know how to proceed.Occurrences: recurring - customer did not record product code: 381233.Product description: catheter iv insyte 20x1.01in pink.Lot/serial #: (b)(6).Expiry date: 8/31/2027.

• Brand Name: BD INSYTE PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18460662
• Report Number: 2243072-2023-02282
• Device Sequence Number: 19624876
• Product Code: FOZ
• UDI-Device Identifier: 30382903812333
• UDI-Public: (01)30382903812333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: CA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2024

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: 381233
• Device Lot Number: 2234335
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 03/25/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/07/2024; 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown