MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3F SL MBPLUS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1173108D5
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation.A lot history review (lhr) of reen3338 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
Material #: s1173108d5, batch #: reen3338.It was reported "microintroducer is not smooth and has bulged edges customer has had this occur with 3-4 times" "patient pain upon insertion." additional information received 10-06-2020: "diagnosis: brain abscess, no infectious disease, 'when placing picc had trouble with microintroducer; when inspecting introducer noticed bulged edges.Due to the bulged edge unable to get introducer through the skin of patient.We had to drop a microez microintroducer kit to finish the picc line placement.This has happened on several occasions.".
Event or Problem Description
It was reported the microintroducer was not smooth and had bulged edges which caused the patient pain upon insertion.Additional information received 10-06-2020: "diagnosis: brain abscess, no infectious disease, 'when placing picc had trouble with microintroducer; when inspecting introducer noticed bulged edges.Due to the bulged edge unable to get introducer through the skin of patient.We had to drop a microez microintroducer kit to finish the picc line placement.This has happened on several occasions.".
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.

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS
• Common Device Name: 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
• MDR Report Key: 10787836
• Report Number: 3006260740-2020-20365
• Device Sequence Number: 19867233
• Product Code: LJS
• UDI-Device Identifier: 00801741155130
• UDI-Public: (01)00801741155130
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 01/31/2021
• Device Model Number: S1173108D5
• Device Catalogue Number: S1173108D5
• Device Lot Number: REEN3338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other