MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Death (1802)

Event Type  Death  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebx0824 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rebx0824) have been reported from the same facility in (b)(4).

Event Description

The doctor reported the cellulitis started at the picc insertion site within one week from the picc insertion and progressed to the hand.It was stated that the patient was in a "very bad comorbid" state.He had end-stage leukemia and was immunocompromised.The doctor reported that the patient succumbed to his condition and passed away after a few days.The hospital reports being a picc user for 3 years and that they "follow appropriate picc maintenance program".

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 that the groshong picc was contaminated, leading to the development of cellulitis and subsequent death was inconclusive due to the condition of the sample.The device used on the patient was not returned for investigation.One unopened groshong picc kit was provided for analysis.No breaches were observed in the sterile barrier.The packaging seal was completely intact and no breaches or gaps were observed in the seal of either the outer or inner packaging.No foreign material or contamination was observed within the packaging.A microscopic examination of the catheter revealed nothing remarkable.Vad products are sterilized using ethylene oxide (eo).The sterilization cycle has been validated by the very conservative over-kill (half cycle) method in accordance with ansi/aami/iso 11135:2014 annex b sterilization of health care productsethylene oxiderequirements for development, validation and routine control of a sterilization process for medical devices (fda consensus standard as of 04/04/2016).Validation and revalidation has demonstrated that the sterilization cycle exceeds the minimum sterility assurance level of 10^-6.It was reported that the patient developed cellulitis within one week of picc placement.The patient was immunocompromised, had leukemia, and was in a very bad comorbid state.The only two complaints from this lot originated from the complainant facility.It was reported that the picc placements were moved from procedure room to bedside; however, due to the reported cases of cellulitis, the picc placements resumed in the procedure room.It is possible that the reported cellulitis was a result of contamination whose source was something other than the catheter.The ifu states, the potential exists for serious complications including the following: exit site infection.A review of the manufacturing records showed that the lot met all release criteria.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 rebx0824 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rebx0824) have been reported from the same facility in (b)(6).

Event Description

The doctor reported the cellulitis started at the picc insertion site within one week from the picc insertion and progressed to the hand.It was stated that the patient was in a "very bad comorbid" state.He had end-stage leukemia and was immunocompromised.The doctor reported that the patient succumbed to his condition and passed away after a few days.The hospital reports being a picc user for 3 years and that they "follow appropriate picc maintenance program".

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8329866
• MDR Text Key: 135852251
• Report Number: 3006260740-2019-00231
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REBX0824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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 Outcome(s): Death