MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no.: 383346, batch no.: unknown.It was reported that during use of the bd saf-t-intima¿ iv catheter safety system the catheter separated from the inserter leaving the wing and the catheter in the patient.The following information was provided by the initial reporter: bd saf-t-intima catheter ref 383346 18ga 1.00in, 1.3 25mm.Separated from the wing portion of the catheter, leaving the wing and catheter in the patient.Remainder of device was removed and iv replaced in patient with new catheter.
Event or Problem Description
Material no.: 383346.Batch no.: unknown.It was reported that during use of the bd saf-t-intima¿ iv catheter safety system the catheter separated from the inserter leaving the wing and the catheter in the patient.The following information was provided by the initial reporter: bd saf-t-intima catheter ref (b)(4) 18ga 1.00in, 1.3 25mm.Separated from the wing portion of the catheter, leaving the wing and catheter in the patient.Remainder of device was removed and iv replaced in patient with new catheter.
Additional Manufacturer Narrative
Additional information: medical device lot #: 8178622.Medical device expiration date: 6/30/2022.Device manufacture date: (b)(6)2018.Investigation summary: a device history review was conducted for lot number 8178622.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.
Event or Problem Description
Material no.: 383346, batch no.: unknown.It was reported that during use of the bd saf-t-intima¿ iv catheter safety system the catheter separated from the inserter leaving the wing and the catheter in the patient.The following information was provided by the initial reporter:.
Additional Manufacturer Narrative
H.6.Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Based on their evaluation of the provided photograph, our engineers have determined that the most likely root cause for this event is a lack of adhesive applied to the tubing tip.H3 other text : see h.10.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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: 9246139
• Report Number: 9610847-2019-00645
• Device Sequence Number: 1410409
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2019

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: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 383346
• Device Lot Number: 8178622
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 10/11/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/22/2019; 12/12/2019
• 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
• Patient Age: 38 YR
• Patient Weight: 89