MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. TUN-L-XL/24

Model Number A-EP-089

Device Problems Retraction Problem (1536); Use of Device Problem (1670); Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 11/03/2014

Event Type  No Answer Provided  

Manufacturer Narrative

On february 2, 2015, epimed received five tun-l-xl catheters; two of the five catheters returned had no visible skive or shear blemish's.Two out of the remaining three catheters were missing pieces of their outer coating.The account was emailed by epimed on february 3, 2015, informing them that two of the five catheters which were returned were missing (fep) catheter coating.On february 10, 2015, the account responded stating "we are sure that no pieces of coating remain in the patient's budy (body)".Due to the account reporting that "no pieces of coating remain in patient's body", epimed did not file an mdr at the time of when the event was reported.(b)(4).Therefore, epimed has opened subsequent complaint file (15-08-001-1, 15-08-001-2, & 15-08-001-3) to document each of the catheters which were skived/sheared.The catheter in question was discovered to have had approximately 4cm the outer (fep) coating sheared and missing from the catheter.In a good faith attempt to follow up with the account/distributor, epimed emailed the distributor, of the catheter in question (mr.(b)(6)).Mr.(b)(6) responded on behalf of the account on july 25, 2016, stating "they are not sure whether a piece of teflon coating remained in the patient's body or not, but they suppose that the piece is still remained in the body.And, the missing pieces of teflon coating haven't been removed from the body.The patient recovered and left the hospital".Due to this newly reported change in information epimed believes that it is necessary to now report this event as an mdr.Epimed suspects that the catheter in question skived/sheared due to the physician's technique.Also, based on the damage to this catheter, epimed believes that the corresponding rx needle may have remained in place during the attempted removal of the catheter in question.To epimed's knowledge, there has been no patient injury or adverse events reported in relation to this incident.(b)(4).

Event Description

On february 2, 2015, epimed was supplied with 5 tun-l-xl catheters, where the account reported the following: "the plastic is peeling off".

• Brand Name: TUN-L-XL/24
• Type of Device: TUN-L-XL/24
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: nathanael wrabel ; 141 sal landrio drive; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 5885566
• MDR Text Key: 52404831
• Report Number: 1316297-2016-00009
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: A-EP-089
• Device Catalogue Number: 155-2542
• Device Lot Number: 11426382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization