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

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.

Manufacturer Narrative

(b)(4) the sample was returned for evaluation.A visual exam was performed and there were no signs of sample use, and no defects were observed.Functional testing was performed and no issues were found.A device history record (dhr) was performed on the lot number of the sample received and no issues or discrepancies were found which could potentially relate to the reported complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

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 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4999165
• MDR Text Key: 23803618
• Report Number: 3004365956-2015-00229
• 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
• Type of Report: Followup
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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