MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PL1355TS

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2014

Event Type  malfunction  

Manufacturer Narrative

The complained product has been checked, the pouch (wpouch 20) used in this product was torn at the plastic film side.It is observed that the tearing could be caused by scratching from outside of the pouch as the torn film was fold to outside of the film.And, refer to ew evaluation summary that the holes on the pouch seemed to be run over by a wheel and the condition of use that pouch was not found right after opening of the shelf box.The shelf box was opened and the pouches were stored at the hospital.The device history record of this complained lot has been reviewed, there is no any damage of pouch detected during the assembly, packing or loading process.The current manufacturing also have been reviewed as follows: - there is no any tool use in the manufacturing process that could cause the scratch on the pouch.- the products have been properly handling in the assembly process , packing process and loading process on the production line.They are always kept in the proper containers, and delivered to the next production station without impact or dropping and no possibility to be rolled over by the wheel.- the finished products and the unit pouches have been 100% inspected in the assembly process and in the packing process before packed into the shelf boxes.- the boxes of products are 100% inspected by qc after sterilization.In case there is any damage on the box.Then, all products inside the box shall be rechecked by qc - the product being shipped are properly cleaned and arranged by warehouse operators and checked by qc.In case any box un-intently dropped or has any damage.Then, all inside products shall be rechecked by qc.From the above reviewing, it is included that the tearing/holes of the pouch of this complained product should not be related to supplier process.

Event Description

It was reported that the pouch was found damaged at the hospital before use.It was torn on the left side like it was scratched.It was further stated that the damaged pouch was not found right after opening the shelf box.The shelf box was opened and the pouches were stored at the hospital and then, when it was taken out from storage, they found 2mm sized damage on a plastic of the pouch.There was no patient complications reported.

Manufacturer Narrative

Received one single dpt kit in a pouch.The upper part of the pouch was opened as received.One side of the pouch was found damaged and the pouch film had (2) holes.The damaged part of the pouch seemed to be run over by a wheel.A trace, which is non-ew label was peeled off was also observed at upper surface of pouch film.A review of the manufacturing records indicated that the product met specification at the time of release.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo,; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo,; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3914055
• MDR Text Key: 11994439
• Report Number: 2015691-2014-01527
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: PL1355TS
• Device Lot Number: EC0236MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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