MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL PUREHUB DISINFECTING CAP STRIP; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number	306597
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of purehub disinfecting cap strips experienced leakage which was noted during use.The following information was provided by the initial reporter: material no: 306597, batch no: unknown.Event description: it was reported that the account has had additional leakages of bd maxzero.In speaking with the account, they feel that these issues occurred after they started using bd purehub as they have been using bd maxzero for years and have never had any issues.
Event or Problem Description
It was reported that an unspecified number of purehub disinfecting cap strips experienced leakage which was noted during use.The following information was provided by the initial reporter: material no: 306597, batch no: unknown.Event description: it was reported that the account has had additional leakages of bd maxzero.In speaking with the account, they feel that these issues occurred after they started using bd purehub as they have been using bd maxzero for years and have never had any issues.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see section h.10.
Additional Manufacturer Narrative
H.6 investigation summary: ten pure hub samples and two bd maxzero needless connectors were received by our quality team for evaluation.The pure hub samples came with the sealed top web.The bd maxzero connectors came each in a ziploc plastic bag.Visual inspection was performed.There are no defects or deformations.The bd maxzero connectors were tested with the pure hub samples; they all showed a leakage at the time the bd maxzero connector was pushed all the way down to the pure hub to get it screwed on.The outside diameter of the bd maxzero connector is smaller than the inner diameter of the pure hub causing the leakage.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the investigation the probable root cause was application.The diameters of both products are not fully aligned, dimensional wise.The bd maxzero has a smaller outside diameter compared to the inner pure hub diameter which leaves a gap of 1/32¿.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that an unspecified number of pure hub disinfecting cap strips experienced leakage which was noted during use.The following information was provided by the initial reporter: material no: 306597, batch no: unknown.Event description: it was reported that the account has had additional leakages of bd maxzero.In speaking with the account, they feel that these issues occurred after they started using bd purehub as they have been using bd maxzero for years and have never had any issues.

• Brand Name: PUREHUB DISINFECTING CAP STRIP
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9260404
• Report Number: 1911916-2019-01141
• Device Sequence Number: 3012549
• Product Code: LKB
• UDI-Device Identifier: 00382903065974
• UDI-Public: 00382903065974
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 306597
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 10/01/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/22/2019; 01/29/2020
• 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