MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F DL POWERPICC RN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number CK000444B

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebn0977 showed no other similar product complaint(s) from this lot number.Device not returned yet.

Event Description

It was reported that the peel away sheath did not peel completely and needed to be cut.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an improper peel was confirmed, and the damage appeared to be manufacturing related.One 5 fr microintroducer sheath was returned for investigation.The tabs had been split and the sheath had been peeled.The tabs split unevenly, which resulted in a ring of red material that remained attached to one tab after the introducer was split apart.The head of the tack used to secure the sheath to one of the peel tabs was exposed due to the uneven break between the tabs.The complaint ¿the peel away sheath did not peel completely and needed to be cut¿ is confirmed.On one of the parts of the sheath was present part of the molding.This part was an excess of resin produced during the molding process.The cause of this is manufacturing related.Internal corrective actions have been taken to address this event.A lot history review (lhr) of rebn0977 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the peel away sheath did not peel completely and needed to be cut.

• Brand Name: 5F DL POWERPICC RN
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7143836
• MDR Text Key: 95822474
• Report Number: 3006260740-2017-02312
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741124044
• UDI-Public: (01)00801741124044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CK000444B
• Device Catalogue Number: CK000444B
• Device Lot Number: REBN0977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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