MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 18G X 1.16IN (1.3 X 30 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number	381344
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2019
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 needle through a the catheter occurred before use with a 18g x 1.16in (1.3 x 30 mm) insyte.The following information was provided by the initial reporter, "needle has already perforated the cathlon when the product is opened, unusable.".
Event or Problem Description
It was reported that needle through a the catheter occurred before use with a 18g x 1.16in (1.3 x 30 mm) insyte.The following information was provided by the initial reporter, "needle has already perforated the cathlon when the product is opened, unusable.".
Additional Manufacturer Narrative
H.6.Investigation: ¿ the complaint is unconfirmed as no photo / samples received ¿ the investigation was not able to confirm what the customer had experience as there were no returned samples/pictures for evaluation.A device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: 18G X 1.16IN (1.3 X 30 MM) INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8918217
• Report Number: 8041187-2019-00665
• Device Sequence Number: 290772
• Product Code: FOZ
• UDI-Device Identifier: 30382903813446
• UDI-Public: 30382903813446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 07/31/2023
• Device Catalogue Number: 381344
• Device Lot Number: 8215484
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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