MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT ACCESSORY,HTD WIRE, INSPIRATORY; BREATHING CIRCUIT

Catalog Number 780-19

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The customer alleges that that breathing circuit melted while in use.The customer alleges that the wires were bunched up (within the circuit) which could have caused a hot spot.No patient injury or harm.

Manufacturer Narrative

(b)(4).Evaluation codes: conclusion(s) - a conclusion code could not be chosen.The complaint was confirmed, but the root cause is unknown.Two pictures of the unit of catalog 780-19 (circuit accessory (htd wire, inspiratory), were received for analysis.They were visually inspected founding a bunch of wires that may have caused the melt of the corrugated tube.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number's (b)(4), (b)(4), (b)(4) and (b)(4) that belong to catalog number 780-19 have been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot numbers in question that can be associated to the complaint reported.The device history records shows that the products were assembled & inspected according to our specifications.Other remarks: the customer complaint was confirmed based on the visual inspection of the received pictures, because a melted section on the corrugated tubing was observed.However, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If device sample becomes available at a later date this complaint will be re-opened.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.A visual exam was performed and it was observed that the circuit was burned/melted at the patient end.It was also detected that there was "bunched" or "gathered" excessive wire at the patient end.Functional testing was performed.The volt/ohm resistance of the circuit was measured to ensure the correct wire was used in the manufacturing of the circuit.The resistance reads 13.7 ohms which is well within the specified tolerance of 12.8 - 14.3 ohms.Based on the physical evidence of the incident, the complaint is confirmed; however, a root cause could not be established.It would be extremely unlikely that the "bunched" or "gathered" wires would have been caused by the manufacturing process.Due to the tightly gathered bunch of wires, it would also be highly unlikely that this condition could have been caused by normal handling/and or shipping.It is possible that there was an accidental separation of the connector at the patient end from the corrugated blue tubing.In a scenario such as that, an undetermined length of wire could be exposed which would have been dragging the return wire loop down the blue tubing toward the patient end.Other remarks: it would be virtually impossible for the exposed wire (loop) to be evenly re-routed in the corrugated blue tubing.An operator or clinician who was attempting to put the circuit into use could have "pushed" the exposed wire back into the end of the circuit which would have resulted in the "bunched" affect as seen in the returned sample.

Event Description

The customer alleges that breathing circuit melted while in use.The customer alleges that the wires were bunched up (within the circuit) which could have caused a hot spot.No patient injury or harm.

• Brand Name: HUDSON CIRCUIT ACCESSORY,HTD WIRE, INSPIRATORY
• Type of Device: BREATHING CIRCUIT
• 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: 4882374
• MDR Text Key: 6059821
• Report Number: 3004365956-2015-00177
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 780-19
• Device Lot Number: 02J100454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• 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