MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 rezj1831 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that a perforation on the catheter was noted before starting the procedure.The device was not used on the patient.
Additional 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 a leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 3fr groshong catheter.The sample was received with an inlaid stylet and appeared free of usage residues.The sample was unremarkable to gross inspection.An attempt to infuse water through the sample using a 12 ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained hydraulic pressurization of the sample.Tactile inspection of the sample was unremarkable.Microscopic inspection of the sample was unremarkable.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.
Additional 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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf803.19.
Event or Problem Description
It was reported that a perforation on the catheter was noted before starting the procedure.The device was not used on the patient.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6340870
• Report Number: 3006260740-2017-00100
• Device Sequence Number: 10931629
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757(17)171028(10)REZJ1831
• Combination Product (Y/N): N
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 7755305
• Device Lot Number: REZJ1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 04/18/2017; 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1