MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recq0546 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a catheter with a tiny hole in the distal tip.No other information was provided.
Event or Problem Description
It was reported a catheter with a tiny hole in the distal tip.No other information was provided.
Additional 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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole is confirmed and was determined to be use related.One 3 fr groshong clearvue catheter with stiffening stylet and flushing hub inserted was returned for evaluation.An initial visual observation showed a small amount of use residue on the returned sample.The sample was flushed with a 12 ml syringe of water and a spraying leak was observed in the catheter between the 5 cm and 6 cm depth markers.A microscopic observation revealed multiple small splits in the catheter at the location of the leak.The orientation and pattern of these splits matched the shape of the braided stiffening stylet within the catheter.Similar damage was observed on the opposite side of the catheter at the same location.The catheter was dissected, and additional damage was observed at the corners of each small split, indicating the damage originated from within the catheter.The shape and extent of the damage observed on and within the returned catheter indicate the catheter was most likely compressed with the stylet still inserted.A lot history review (lhr) of recq0546 showed no other similar product complaint(s) from this lot number.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9768721
• Report Number: 3006260740-2020-00672
• Device Sequence Number: 2495640
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 7755305
• Device Lot Number: RECQ0546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1