MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that the catheter had migrated through the patient's arm, disconnected from its repair and requiring medical intervention (vascular surgery team) to remove it.No other information was provided.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheter detachment/breakage was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 4fr s/l groshong nxt catheter.The depicted portion of the device included the distal region of the assembled connector, including the distal segment and part of the proximal segment.The connector appeared to be secured using a statlock, which was attached to the skin of a patient.The catheter shaft was detached from the connector and was not visible in the photograph.Catheter separation from the connector assembly was evident in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include improper catheter/connector assembly and sharp instrument contact.A lot history review (lhr) of refs4760 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refs4760) have been reported from the same facility in the (b)(6).

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheter detachment/breakage was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 4fr s/l groshong nxt catheter.The depicted portion of the device included the distal region of the assembled connector, including the distal segment and part of the proximal segment.The connector appeared to be secured using a statlock, which was attached to the skin of a patient.The catheter shaft was detached from the connector and was not visible in the photograph.Catheter separation from the connector assembly was evident in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include improper catheter/connector assembly and sharp instrument contact.H3 other text: evaluation findings are in section h11.

Event Description

It was reported that the catheter had migrated through the patient's arm, disconnected from its repair and requiring medical intervention (vascular surgery team) to remove it.No other information was provided.Additional information received: could you tell us what the current status of the patient is? patient died as a result of generalized infection, which has nothing to do with the catheter event.What medication was being administered? none.What was the source of the reported infection? probable abdominal focus.Was the catheter infected? no.Did the procedure to remove the embolized catheter cause or contribute to the patient's condition deteriorating in anyway? no.How did the patient tolerate the procedure? uneventfully how was the embolized catheter discovered? the catheter detached from the connecting piece, and there was medication leakage, so we realized that it was detached.When did the patient expire? 21-apr-2022.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14189728
• MDR Text Key: 289902249
• Report Number: 3006260740-2022-01443
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REFS4760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female