MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 F SL POWERPICC SOLO 3CG N FULL; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETE

Catalog Number 2194108

Device Problem Mechanics Altered (2984)

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

Event Date 01/02/2017

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 reau2173 showed one other similar product complaint(s) from this lot number.Device not yet returned for evaluation.

Event Description

It was reported that when the healthcare professional (hcp) placed the picc, they had difficulty splitting the introducer.Scissors were used by the hcp to split the introducer.No patient injury was reported.

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, trend 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 introducer which was difficult to split is confirmed based on the state of the device.The cause is determined to be manufacturing-related.The device returned was one 4.5 fr introducer sheath, without the dilator, reportedly from a 4 fr single lumen picc solo catheter full tray with 3cg tps.Visual observation found that the microintroducer had been completely peeled.A large chunk of plastic from one of the tabs was retained on the other tab, such that a ring of material remained on one side, which had a circular impression within it.The halves of the sheath tube itself appeared to have undergone a complete and smooth peel; jagged edges, etc.Were not found.Microscopic evaluation found whitened plastic at and around the point at which the plastic portion in question, indicating strain.The point at which the ring of material on the tabs had been broken appeared very ragged, with damage reminiscent of tool marks.On the side not retaining the ring of material, an area of plastic not normally present was found integrated with the tab, which manifested a circular impression similar to that found on the ring of material attached to the other tab.Residue was found both on the sheath tubing and the tabs.From the appearance of the tabs of this microintroducer, especially in comparison to a sample, it is clear that extra material is present on/within the tabs, altering the shape thereof.It is also clear that microintroducer did not peel as intended and part of the material of one tab remained with the other tab instead of splitting away with its own tab.This complaint is confirmed.This device is manufactured in a bard facility, and this complaint is therefore manufacturing related.This device will be forwarded to the manufacturing site for further evaluation.

Event Description

It was reported that when the healthcare professional (hcp) placed the picc, they had difficulty splitting the introducer.Scissors were used by the hcp to split the introducer.No patient injury was reported.

• Brand Name: 4 F SL POWERPICC SOLO 3CG N FULL
• Type of Device: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETE
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6273937
• MDR Text Key: 65913467
• Report Number: 3006260740-2017-00016
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Public: (01)(17)180128(10)REAU2173
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 2194108
• Device Lot Number: REAU2173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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