MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERMIDLINE CATHETER, 4F SL

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redu2772 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "there were what appears to be card board shavings in the sealed kit".The kit was not used on a patient.
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material within a kit is confirmed and was determined to be manufacturing related.One 4 fr single lumen powermidline catheter kit was returned for evaluation.An initial visual observation showed the kit was returned open, but the contents appeared unused.Multiple small pieces of a brown material were observed on the outside of the csr wrap within the kit.A larger piece of this material was observed in the adhesive strip underneath the outer ¿side car¿ of the kit.A microscopic observation revealed the material pieces were mostly flat and fibrous.Small bits of blue and green were observed in some of the material pieces.The material was also observed to break apart somewhat easily when handled.The investigation was forwarded to the manufacturing facility for further evaluation.Reynosa evaluation: complaint due to ¿cardboard shavings in the sealed kit¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross, microscopic visual evaluation performed at vad lab the following was concluded: several residues of cardboard shavings were found to be deposed over the blue crs wrap.The foreign material is brown color similar to the color material of boxes used for packaging.This condition makes the kit unsafe for our customer.Therefore, the cause of this condition is manufacturing related.As part of reinforcement about this issue, an awareness communication was provided to all personnel involved on this operation.A lot history review (lhr) of redu2772 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "there were what appears to be "cardboard" shavings in the sealed kit".The kit was not used on a patient.

• Brand Name: POWERMIDLINE CATHETER, 4F SL
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9913827
• Report Number: 3006260740-2020-01100
• Device Sequence Number: 11581114
• Product Code: PND
• UDI-Device Identifier: 00801741188084
• UDI-Public: (01)00801741188084
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000799A
• Device Lot Number: REDU2772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1