MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24G X 0.56IN (0.7 X 14 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number	381211
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that defects occurred during use with a 24g x 0.56in (0.7 x 14 mm) insyte.The following information was provided by the initial reporter, "customer description: difficulty to pierce the skin plastic tip not always intact when needle is progressed through plastic several clinicians have had issues with this cannula rotates, no lock one cannula split.".
Additional Manufacturer Narrative
H.6.Investigation: 1 unused sample was returned for evaluation.Needle pierced through catheter was observed from the sample.The complaint is confirmed and product is out of specification.Needle pierced through catheter could have occurred during assembly of catheter and cannula or during product application when the product was manipulated.The batch produced is before the implementation of the capa#590840.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
Event or Problem Description
It was reported that defects occurred during use with a 24g x 0.56in (0.7 x 14 mm) insyte.The following information was provided by the initial reporter, "customer description: difficulty to pierce the skin.Plastic tip not always intact when needle is progressed through plastic.Several clinicians have had issues with this cannula.Cannula rotates, no lock.One cannula split.".

• Brand Name: 24G X 0.56IN (0.7 X 14 MM) INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8713436
• Report Number: 8041187-2019-00466
• Device Sequence Number: 11194997
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 381211
• Device Lot Number: 8355532
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other