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

Catalog Number 383312

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: three photos were received for evaluation.A review of the provided photos confirmed damage to the extension tubing.We were unable to confirm the damage to the manufacturing process.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.Investigation conclusion: reported defect was confirmed in images received; however, after evaluate 3 images, we cannot confirm or associate the reported defect to manufacturing process.This defect is not common in our process.Based on dhr review for material reported, the product lot met the final assembly specifications and qa inspections; however customer detected a damage in the pvc tubing.Currently, there is a sampling plan in place lot by lot to look for this kind of damage and according to internal process rejects (qn¿s) database, no issues like this have been reported.An inspection was performed on final assembly looking for any activity that could cause this damage and nothing extraordinary came up.Personnel is properly trained on their activities.Note: slide clamp only is placed in the tubing, never is clamped.No corrective action required at the failure.Process fmea (b)(4) was reviewed and there are proper controls in place to detect product malfunctions.Root cause description: based on investigation results to date, the root cause could not be determined.

Event Description

It was reported that the nurse found congealed blood on the third day of infusion using the bd saf-t-intima¿ iv catheter safety system tubing.The e-tubing near the clip was split and had blood return in the tubing.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7580011
• MDR Text Key: 110705852
• Report Number: 9610847-2018-00173
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833122
• UDI-Public: 00382903833122
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 383312
• Device Lot Number: 7083679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other