MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that saf-t-intima w/y adapter gn 18ga x 1.0in needle was broken.The following information was provided by the initial reporter: nurse was performed puncturing for the patient, during process to delieve the needle, it was found that needle was suddenly broken when it was withdrawn with 2 mm, the nurse heard a relatively crisp sound, customer suspected that there was a problem with the quality before the puncturing.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of a catheter breaking after placement was received from the customer.A sample was provided to aid in the investigation of this defect.Through visual inspection the customer complaint was confirmed.During investigation it was found that the tubing had an insufficient amount of solvent.A device history record review was completed by our quality engineer team for provided lot number 9122995.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The root cause for this defect was determined to be an insufficient amount of solvent added during manufacturing.
Event or Problem Description
It was reported that saf-t-intima w/y adapter gn 18ga x 1.0in needle was broken.The following information was provided by the initial reporter: nurse was performed puncturing for the patient, during process to delieve the needle, it was found that needle was suddenly broken when it was withdrawn with 2 mm, the nurse heard a relatively crisp sound, customer suspected that there was a problem with the quality before the puncturing.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER GN 18GA 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
• MDR Report Key: 11312178
• Report Number: 9610847-2021-00066
• Device Sequence Number: 10983667
• Product Code: FOZ
• UDI-Device Identifier: 00382903833467
• UDI-Public: 00382903833467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/25/2021

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: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383346
• Device Lot Number: 9122995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1