MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383085

Device Problem Product Quality Problem (1506)

Patient Problems Abscess (1690); Phlebitis (2004); Staphylococcus Aureus (2058)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system was used and resulted in staphylococcus aureus.Phlebitis occurred on 3 separate occasions.The following information was provided by the initial reporter: patient appeared abscess on the puncture site, then using pus to fungi culture, the result was staphylococcus aureus.There were 3 puncture site phlebitis in total.(b)(6): this is the first time that the hospital's neonatology department used the bd xiangma 24g short catheter straight indwelling needle, and the bd xiangma 24 straight indwelling needle has been used before, and this month has started three times since the use of the short catheter indwelling needle.There was an adverse event of abscess at the puncture point after the needle was pulled out (two of which occurred after discharge).The nurse also reported that the needle was more enlarged after the short catheter indwelling needle was used, which was inconsistent with the product characteristics of the indwelling needle itself, and since the use of this batch the incidence of posterior phlebitis of the short catheter is higher.The current department suspects that there is a problem with the quality of the indwelling needle.The hospital has arranged for the fungus culture of the pus of the child.The result is still to be investigated.An unopened return to hope factory in xiangma can eliminate product quality problems through product inspection and dispel customer concerns.The result is staphylococcus aureus.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 7178244.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, samples were obtained for evaluation and testing; each unit tested for sterility passed.Similarly, this lot was treated and received a certificate of conformance for sterility.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system was used and resulted in staphylococcus aureus.Phlebitis occurred on 3 separate occasions.The following information was provided by the initial reporter: patient appeared abscess on the puncture site, then using pus to fungi culture, the result was staphylococcus aureus.There were 3 puncture site phebilits in total.Google translation: this is the first time that the hospital's neonatology department used the bd xiangma 24g short catheter straight indwelling needle, and the bd xiangma 24 straight indwelling needle has been used before, and this month has started three times since the use of the short catheter indwelling needle.There was an adverse event of abscess at the puncture point after the needle was pulled out (two of which occurred after discharge).The nurse also reported that the needle was more enlarged after the short catheter indwelling needle was used, which was inconsistent with the product characteristics of the indwelling needle itself, and since the use of this batch the incidence of posterior phlebitis of the short catheter is higher.The current department suspects that there is a problem with the quality of the indwelling needle.The hospital has arranged for the fungus culture of the pus of the child.The result is still to be investigated.An unopened return to hope factory in xiangma can eliminate product quality problems through product inspection and dispel customer concerns.The result is staphylococcus aureus.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8499324
• MDR Text Key: 141498096
• Report Number: 3006948883-2019-00266
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2020
• Device Catalogue Number: 383085
• Device Lot Number: 7178244
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other