MAUDE Adverse Event Report: TELEFLEX MEDICAL PU MDP-60K DISP PUNCH 6.0MM; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number MDP-60K

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that when the doctor used the 6.0mm punch on the external iliac artery he said it disintegrated and stuck to the tissue.He had difficulty removing it.The punch caused damage to the tissue and the external iliac artery.It necessitated us going back into slush.The damage to the tissue required us to call the vascular team to come in and repair the artery with a graft.The patient's condition is unknown at this time.The device and packaging were saved and brought to clinical engineering for evaluation.An exemplar from the same lot was also obtained.It seems a piece of tissue was jammed between the cutting ring and the center plunger and the plastic ring on the end of the instrument broke off when the action was reversed, making it impossible to clear the jammed tissue.Exemplar device from same lot was tested with a piece of rubber glove.While it punched a hole in the glove, the punched out section jammed in the cutter.When trying to free the jam, the plastic ring popper off and flew across the room and was lost.So there are two issues; the cutter tends to jam and the plastic ring on the distal end of the device is easy to break off when trying to clear a jam.

Manufacturer Narrative

Qn# (b)(4).The device history record of batch number 74h1702723 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.One sample of fg mdp-60k was received from customer for evaluation.Sample doesn't have any signs of use, however it was observed that the metal parts that perform the cut are jammed.Additionally, no o-ring is present.A fully dimensional inspection will be performed as part of the investigation that will be carried out under the nonconformance.Preventive maintenance records of the dukane welder duw-14 which is the equipment that welds the o-ring was reviewed, records of the months of august and september 2017 were requested since the production lot occurred on september 04, 2017.No malfunctions were found that could cause the issue reported.Other remarks: based on the inspection made on the sample received (jammed and missing o-ring), the reported issue has been confirmed, however the cause of both conditions is unknown.Therefore the nonconformance has been created in order to conduct some additional testing to determine the root cause.Based on the conditions observed on the sample received (jammed and loose o-ring) the customer complaint is confirm.Nonconformance has been issued in order to obtain the root cause.Additionally, the personnel of the manufacturing and quality departments have been notified as awareness.

Event Description

It was reported that when the doctor used the 6.0mm punch on the external iliac artery he said it disintegrated and stuck to the tissue.He had difficulty removing it.The punch caused damage to the tissue and the external iliac artery.It necessitated us going back into slush.The damage to the tissue required us to call the vascular team to come in and repair the artery with a graft.The patient's condition is unknown at this time.The device and packaging were saved and brought to clinical engineering for evaluation.An exemplar from the same lot was also obtained.It seems a piece of tissue was jammed between the cutting ring and the center plunger and the plastic ring on the end of the instrument broke off when the action was reversed, making it impossible to clear the jammed tissue.Exemplar device from same lot was tested with a piece of rubber glove.While it punched a hole in the glove, the punched out section jammed in the cutter.When trying to free the jam, the plastic ring popper off and flew across the room and was lost.So there are two issues; the cutter tends to jam and the plastic ring on the distal end of the device is easy to break off when trying to clear a jam.

• Brand Name: PU MDP-60K DISP PUNCH 6.0MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7406628
• MDR Text Key: 104674554
• Report Number: 3004365956-2018-00111
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Catalogue Number: MDP-60K
• Device Lot Number: 74H1702723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention