MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC SOLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number CK000663A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2018

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 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 a broken stylet is confirmed but the cause could not be determined.One photo sample of two segments of what appears to be a stylet were returned for investigation.The break surface characteristics could not be distinguished from the photo sample provided.There appears to be flakes of use residue around the stylet.Based on the description of the reported event and photo sample returned, possible contributing factors include cut stylet during catheter trimming and advancement or retraction of a kinked stylet against resistance.The complaint of a broken stylet is confirmed but the exact cause could not be determined.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebw2077 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient came to the emergency department with complaints of chest pain and cough.It was discovered during the diagnostic workup that the patient had a linear thin metallic foreign body in the left hilum.The patient had a pulmonary artery angiogram with wire fragment retrieval on (b)(6) 2018.It is assumed that the event allegedly occurred during placement on (b)(6) 2018 and discovered (b)(6) 2018 when that patient went to the hospital.It was also noted that the fragment further broke into two pieces after retrieval by radiology department.

• Brand Name: DOT PPICC SOLO
• 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: 7425265
• MDR Text Key: 105397878
• Report Number: 3006260740-2018-00673
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741134821
• UDI-Public: (01)00801741134821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2018

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 Catalogue Number: CK000663A
• Device Lot Number: REBW2077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Age: 75 YR
• Patient Weight: 72