MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE PNK 20GA X 1.88IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	381237
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
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 pnk 20ga x 1.88in leaked.The hospitalized patient 10-10 to do enhanced ct.The nurse in accordance with the routine operation connected to the indwelling needle high-pressure syringe, indwelling needle tubing without pressure, twisting and so on, open the locking buckle of the indwelling needle, to 3.0ml / s speed injection of saline 20m rushing tube, the patient in addition to a sense of cool rushing feeling, did not complain of pain and other discomforts.The nurse observed that there was no localized leakage at the puncture site, but observed the enhancement of the machine display, and the flushing curve was not smooth.So again to 3.0m / s speed injection of saline 20ml to, rushing tube process found that the indwelling needle heparin cap end of the pipeline rupture liquid outflow and a slight sense of wrinkles, immediately stop the operation.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current controls, there are outgoing and in-process visual inspections in place to check for catheter adapter and tubing damage.There is also a daily outgoing functional test in place to check for catheter leakage.As no photo or sample was returned, actual root cause could not be established.
Event or Problem Description
The hospitalized patient 10-10 to do enhanced ct.The nurse in accordance with the routine operation connected to the indwelling needle high-pressure syringe, indwelling needle tubing without pressure, twisting and so on, open the locking buckle of the indwelling needle, to 3.0ml / s speed injection of saline 20m rushing tube, the patient in addition to a sense of cool rushing feeling, did not complain of pain and other discomforts.The nurse observed that there was no localized leakage at the puncture site, but observed the enhancement of the machine display, and the flushing curve was not smooth.So again to 3.0m / s speed injection of saline 20ml to, rushing tube process found that the indwelling needle heparin cap end of the pipeline rupture liquid outflow and a slight sense of wrinkles, immediately stop the operation.

• Brand Name: BD INSYTE PNK 20GA X 1.88IN
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 19974159
• Report Number: 2243072-2024-00894
• Device Sequence Number: 7115428
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 381237
• Device Lot Number: 3215236
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown