MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 18G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen2159 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "recently the midlines that we are using it seems the catheter is flared out and hard to penetrate the skin.".

Event Description

It was reported "recently the midlines that we are using it seems the catheter is flared out and hard to penetrate the skin." ten devices were returned.This report addresses the first device.

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 difficult catheter insertion was confirmed and the cause was manufacturing-related.The product returned for evaluation was ten 18ga x 10cm powerglide pro midline catheter assemblies.All ten samples were received in their sealed packages.Microscopic inspection samples revealed irregular catheter tips.The catheter tips flared away from the needle shafts.The transition between the catheters and the needles appeared rough.The irregular and outward flaring catheter tips resulted in rough transitions between the introducer needles and the catheters.The catheter tips appeared to have been improperly formed during device manufacture.Photographs have been forwarded to the manufacturing site for further evaluation.----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to ¿catheter is flared out and hard to penetrate the skin¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual and microscopical visual performed by vad field assurance the following was concluded: the catheter tip was found to be malformed.A rough transition between the needle shaft and the catheter results in the difficulty while attempting to insert through the patient¿s skin.This condition was caused during the catheter tipping process and it makes the device unusable for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of reen2159 showed no other similar product complaint(s) from this lot number.

• Brand Name: PG PRO 18G 10CM BASIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10096344
• MDR Text Key: 194947667
• Report Number: 3006260740-2020-01851
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (y/n): N
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: F118100
• Device Lot Number: REEN2159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1