MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR, 028 NEB, INTL ; ADAPTOR

Catalog Number 403128

Device Problem Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No visual, dimensional and functional inspection can be performed since the device sample is not available for eval.Failure mode could not be duplicated since is unk the reason why the aquapak is leaking, however functional test was performed on 30 subassembly (p/n: 12136) no issues or discrepancies were found.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of the device sample.It is necessary to have the device sample in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.The personnel involved in the mfg process were notified of this complaint.

Event Description

The customer alleges that the device is leaking.

• Brand Name: HUDSON ADAPTOR, 028 NEB, INTL
• Type of Device: ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd. ; morrisville , NC 27560 ; 9194334965
• MDR Report Key: 4999164
• MDR Text Key: 23803718
• Report Number: 3004365956-2015-00228
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 403128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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